D	C54451	Medical Device Problem	C63023	Defective Component	Problem associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use.	Defective Component	2292	Problem associated with a device component having flaws of dimensional deviations greater than acceptable for the intended use.	IMDRF:A0202
D	C54451	Medical Device Problem	C63250	Defective Device	Problem associated with having flaws or dimensional deviations greater than acceptable for the intended use of the device.	Defective Device	2588	Problem associated with having flaws or dimensional deviations greater than acceptable for the intended use of the device.	IMDRF:A0203
D	C54451	Medical Device Problem	C63015	Device Damaged Prior to Use	Problem associated with packaging or shipping damage prior to the use of a device.	Device Damaged Prior to Use	2284	Problem associated with packaging or shipping damage prior to the use of the device.	IMDRF:A0204
D	C91800	Cause Investigation - Type of Investigation	C139452	Testing of Patient Sample or Reference Material Using Manufacturer's Device	The investigation employed relevant empirical testing of a patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	Testing of Patient Sample or Reference Material Using Manufacturer's Device	4106	The investigation employed relevant empirical testing of a patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B08
D	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50787	Undesired Nerve Stimulation	Unintended reaction in nervous system caused by electrical stimulation.	Undesired Nerve Stimulation	1980	Unintended reaction in nerve system caused by electrical stimulation.	IMDRF:E0138
D	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C187283	Upper Respiratory Tract Injury	Mechanical or chemical injuries to the upper airways, including trachea, pharynx and larynx.	Upper Respiratory Tract Injury	4599	Mechanical or chemical injuries to the upper airways, including trachea, pharynx and larynx.	IMDRF:E0753
D	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50603	Implant Failure	Malfunction of a medical implant.	Failure of Implant	1924	Malfunction of a medical implant.	IMDRF:E2107
D	C171094	Health Effects - Health Impact	C187376	Inadequate Treatment/Disease Progression	The worsening of a disease over time due to inadequate treatment.	Inadequate Treatment/Disease Progression	4651	The worsening of a disease over time due to inadequate treatment.	IMDRF:F1006
D	C171094	Health Effects - Health Impact	C50912	Adverse Event without Patient Involvement	No patient involvement when the adverse event occurred.	No Patient Involvement	2645	No patient involvement when the adverse event occurred (for example happened during set-up or cleaning).	IMDRF:F27
A	C54451	Medical Device Problem	C217073	Failure to Degrade	Failure of a material to degrade, absorb, dissolve, etc. in an appropriate manner.	Failure to Degrade	4084	Failure of a material to degrade, absorb, dissolve, etc. in an appropriate manner, when the material is expected to do so.	IMDRF:A0416
A	C54451	Medical Device Problem	C217071	Unstable Impedance	The impedance varies without being consistently too high or too low.	Unstable Impedance	4085	The impedance varies without being consistently too high or too low.	IMDRF:A072203
A	C54451	Medical Device Problem	C217072	Unexpected Deactivation Issue	Problem associated with a device deactivating during use.	Unexpected Deactivation	4086	Problem associated with a device deactivating during use.	IMDRF:A150106
A	C91800	Cause Investigation - Type of Investigation	C217066	Testing of Patient Sample Using Manufacturer's Device	Empirical testing of a patient sample using the device (usually an IVD) involved in the reported adverse event or an identical device.	Testing of Patient Sample Using Manufacturer's Device	4123	The investigation employed relevant empirical testing of a patient sample using the device (usually an IVD) involved in the reported adverse event or an identical device. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B26
A	C91800	Cause Investigation - Type of Investigation	C217067	Testing of Reference Material Using Manufacturer's Device	Empirical testing of a reference material using the device (usually an IVD) involved in the reported adverse event or an identical device.	Testing of Reference Material Using Manufacturer's Device	4124	The investigation employed relevant empirical testing of a reference material using the device (usually an IVD) involved in the reported adverse event or an identical device. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.	IMDRF:B27
A	C91800	Cause Investigation - Type of Investigation	C217054	Device Lost in Transit	The device has been returned by the user but not received for testing.	Device Lost in Transit	4125	The actual device involved in the adverse event has been returned by the user but not received for testing.	IMDRF:B28
A	C91800	Cause Investigation - Type of Investigation	C217074	Device Data not Available for Manufacturer Analysis	Device data is not available for analysis by the manufacturer.	Device Data not Available for Required Analysis	4126	Device data such as software logs are not available for analysis by the manufacturer	IMDRF:B29
A	C91800	Cause Investigation - Type of Investigation	C217056	Device Image Analysis	Review of images of the device, and/or procedural or diagnostic images.	Analysis of Images	3300	The investigation involved review of images of the device, and/or procedural or diagnostic images.	IMDRF:B30
A	C91800	Cause Investigation - Type of Investigation	C217060	Labeling Review	A review of the reported information against the product labelling, including instructions for use.	Labelling Review	36	A review of the reported information against the product labelling, including instructions for use was conducted to determine if the complaint resulted from inadequacies in the product labelling or a failure by the user to adhere to the labelling. Note: labelling review alone is not sufficient as an investigation for the incident.	IMDRF:B31
A	C91800	Cause Investigation - Type of Investigation	C217068	Analysis of Service/Maintenance Records	The analysis of the service history or maintenance records for the device involved.	Analysis of Service/Maintenance Records	3316	The investigation involved the analysis of the service history or maintenance records for the device involved.	IMDRF:B32
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C217079	Vasospasm	Sudden and often, paroxysmal contractions of the muscular wall of blood vessels.	Vasospasm	2128	Contraction of muscular walls of blood vessels	IMDRF:E0522
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C217057	False Lumen Perfusion Post EVAR	Persistent blood flow in the false lumen of a dissection following an endovascular aortic repair (EVAR) procedure.	False Lumen Perfusion	4914	Persistent blood flow in the false lumen of a dissection following an endovascular aortic repair (EVAR) procedure.	IMDRF:E0523
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C99019	Pneumopericardium	The presence of air in the pericardial cavity. Causes include chest injury in adults, and respiratory distress syndrome in infants.	Pneumopericardium	4915	A collection of air or gas in the pericardial cavity.	IMDRF:E0628
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C37999	Palpitation	An unpleasant sensation of irregular and/or forceful beating of the heart.	Palpitations	2467	The feeling of having a fast-beating, fluttering or pounding heart.	IMDRF:E0629
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C217059	Mechanical Respiratory Tract Injury	Mechanical injuries to the upper and/or lower airways.	Mechanical Respiratory Tract Injury	4916	Mechanical injuries to the upper and/or lower airways. For chemical injuries or exposure use E170401 - Caustic/Chemical Burns or E2003 - Chemical Exposure	IMDRF:E0759
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C2888	Atelectasis	The collapse of part or the entire lung due to airway obstruction, infection, tumor, or general anesthesia.	Atelectasis	4917	Incomplete expansion of a lung or a portion of a lung; or portion of the lung collapses or becomes airless, often due to a blockage in the airway.	IMDRF:E0760
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C217061	Nasal Dryness	Lack of moisture in the nasal mucosa.	Nasal Dryness	4918	Lack of moisture in the nasal mucosa	IMDRF:E0761
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C217076	Eye Strain/Fatigue	A feeling of general eye weakness/fatigue.	Eye Strain/Fatigue	4919	A feeling of general eye weakness/fatigue. (e.g. asthenopia).	IMDRF:E0860
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C2944	Cholesteatoma	A pathologic process characterized by the proliferation of keratinizing squamous epithelium resulting in the accumulation of keratin and cells in the middle ear and/or mastoid.  It may be congenital or acquired.  If left untreated, it may increase in size and destroy adjacent structures.	Cholesteatoma	4920	An abnormal growth of skin cells in the middle ear, with or without infection. May be invasive and can erode neighboring structures including bone.	IMDRF:E0911
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C35348	Ear Injury	Trauma to the ear.	Ear injury	4921	Injury to the outer, middle or inner ear.	IMDRF:E0912
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C217077	Cerumen Impaction	A buildup and/or blockage of earwax in the ear canal.	Cerumen impaction	4922	A buildup and/or blockage of earwax in the ear canal.	IMDRF:E0913
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C28228	Metabolic Acidosis	Increased acidity in the blood secondary to acid base imbalance. Causes include diabetes, kidney failure and shock.	Metabolic Acidosis	4923	An increase in the hydrogen ion concentration in the systemic circulation that results in an abnormally low serum bicarbonate level.	IMDRF:E1213
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C3123	Hyperthyroidism	Overactivity of the thyroid gland resulting in overproduction of thyroid hormone and increased metabolic rate. Causes include diffuse hyperplasia of the thyroid gland (Graves' disease), single nodule in the thyroid gland, and thyroiditis. The symptoms are related to the increased metabolic rate and include weight loss, fatigue, heat intolerance, excessive sweating, diarrhea, tachycardia, insomnia, muscle weakness, and tremor.	Hyperthyroidism	4924	Abnormally high levels of thyroid hormone	IMDRF:E1214
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C114478	Metabolic Alkalosis	Abnormally increased pH levels in the blood due to excessive loss of acid and/or accumulation of base.	Metabolic Alkalosis	4925	A disorder characterized by abnormally high alkalinity (low hydrogen-ion concentration) of the blood and other body tissues.	IMDRF:E1215
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C217053	Loose Skeletal Fragments in Synovial Joint	Presence of fibrous, bony, cartilaginous or osseocartilaginous fragments in a synovial joint.	Loose body in joint	4926	Presence of fibrous, bony, cartilaginous or osseocartilaginous fragments in a synovial joint.	IMDRF:E1652
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C217058	Unspecified Skin and Subcutaneous Tissue Problem	A non-specific problem with the skin or subcutaneous tissue.	Unspecified Skin and Subcutaneous Tissue Problem	4927	The report describes a non-specific problem with the skin or subcutaneous tissue. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist.	IMDRF:E1729
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C217069	Inappropriate Device Stimulation of Tissue	Unintended reaction in a tissue caused by electrical stimulation.	Inappropriate Device Stimulation of Tissue	4928	Unintended reaction in a tissue (e.g. nerve, muscle) caused by electrical stimulation	IMDRF:E2131
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C217070	Medical Device Site Inflammation	Inflammation local to an implanted or invasive medical device.	Medical Device Site Inflammation	4929	Inflammation local to an implanted or invasive medical device.	IMDRF:E2132
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C119203	Decreased Exercise Tolerance	A reduction in the ability to perform or withstand activities that induce physical or mental exertion.	Exercise capacity decreased	4930	Reduced ability of the body to perform strenuous activities	IMDRF:E2352
A	C171094	Health Effects - Health Impact	C217055	Emergency Hospital Transfer	Patient required emergency transfer to a different facility because of the need for an additional level of care.	Emergency Hospital Transfer	4658	Patient required emergency transfer to a different facility because of the need for an additional level of care.	IMDRF:F0802
A	C171094	Health Effects - Health Impact	C217062	Inappropriate Treatment	Patient received treatment which was unnecessary or excessive.	Inappropriate Treatment	4659	Patient received treatment which was unnecessary or excessive. This includes treatment following a false positive diagnosis and excessive stimulation or shock delivery. For drug or radiation overdose use F1005 or child term.	IMDRF:F1009
A	C171094	Health Effects - Health Impact	C217063	Inadequate Treatment	Patient received inadequate or insufficient treatment of an appropriate type.	Inadequate Treatment	4660	Patient received inadequate or insufficient treatment of an appropriate type. This includes inadequate stimulation or shock delivery. For inappropriate treatment use F1009. For drug or radiation underdose use F1004 or child term.	IMDRF:F1010
A	C171094	Health Effects - Health Impact	C217065	Ventilation Assistance	Ventilation assistance or clinically significant extension of existing ventilation.	Ventilation	4661	Patient required ventilation or clinically significant extension of existing ventilation	IMDRF:F2309
A	C171094	Health Effects - Health Impact	C217083	Disease Progression related to Device Performance	The worsening of a disease over time related to device performance.	Disease Progression	4662	The worsening of a disease over time related to device performance.	IMDRF:F30
A	C171094	Health Effects - Health Impact	C217078	Therapy Stopped	Patient treatment aborted, or unable to be completed.	Cancelled/Aborted Treatment/Therapy	4663	Patient treatment aborted, or unable to be completed. This applies to cases where there is no information whether the treatment will be carried out at a later time, or where it is known that treatment will not go ahead. If it is known that the treatment has been, or will be, carried out later then use F05 - Delay to Treatment/ Therapy	IMDRF:F31
A	C54577	Medical Device Component	C217064	Feedthrough Capacitor	A low-resistance channel between contact points on both sides of a circuit system.	Feedthrough Capacitor	4782	A component used to carry a current from an enclosing. Ensures that hermeticity is maintained.	IMDRF:G0201208
A	C54577	Medical Device Component	C50014	Solder Joint Device	A connection between objects formed by solder.	Solder Joint	511	Joint between electrical components, often to a printed circuit board	IMDRF:G02041
C	C91802	Cause Investigation - Investigation Conclusion	C91872	Adverse Event Related to Patient Anatomy and/or Condition	The patient's condition, disease or anatomy is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced the adverse event.	Adverse Event Related to Patient Anatomy and/or Condition	50	The patient's condition, disease or anatomy is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced the adverse event.	IMDRF:D1001
C	C54451	Medical Device Problem	C133578	Application Program Freezes or Fails to Launch	Problem associated with an application program which freezes and/or fails to launch.	Application Program Freezes or Fails to Launch	4031	Problem associated with an application program which freezes and/or fails to launch.	IMDRF:A110201
C	C171094	Health Effects - Health Impact	C50421	Surgical Procedure Cancelled	Termination of a surgical intervention.	Cancelled/Aborted Surgical Procedure	2563	Surgical procedure aborted, or unable to be completed. This applies to cases where there is no information whether the procedure will be carried out at a later time, or where it is known that surgery will not go ahead.If it is known that the procedure has been, or will be, carried out later then use F1909 - Surgical Procedure Delayed	IMDRF:F1910
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C187282	Endoleak	Persistent blood flow/pressure in the aneurysm sac following an endovascular aneurysm repair (EVAR) procedure.	Clinical Endoleak	4843	The observed patient condition is persistent blood flow/pressure in the aneurysm sac following an endovascular aneurysm repair (EVAR) procedure. Where other patient signs and symptoms indicate the presence of an endoleak those signs and symptoms should be coded.	IMDRF:E2121
C	C91801	Cause Investigation - Investigation Findings	C92043	Contamination of Device by Foreign Material from Environment	A device that experienced problems due to ingress or coating of dust, dirt or other foreign material.	Contamination of Device by Foreign Material from Environment	646	A device that experienced problems due to ingress or coating of dust, dirt or other foreign material	IMDRF:C1502
C	C91801	Cause Investigation - Investigation Findings	C92040	Deformation/Distortion Problem	Problems caused by changes in the shape or size of the device due to an applied force. This can be a result of tensile forces (pulling), compressive forces, shear, bending, knotting, or torsion.	Deformation/Distortion Problem	3211	Problems caused by changes in the shape or size of the device due to an applied force. This can be a result of tensile forces (pulling), compressive forces, shear, bending, knotting, or torsion.	IMDRF:C070601
C	C54451	Medical Device Problem	C62925	Device Damaged Prior to Receipt by User	Problem associated with packaging or shipping damage prior to receipt by the user.	Device Damaged Prior to Receipt by User	1570	Problem associated with packaging or shipping damage prior to receipt by the user.	IMDRF:A0207
C	C54451	Medical Device Problem	C193377	Post-EVAR Endoleak	Problem associated with persistent blood flow/pressure in the aneurysm sac following an endovascular aneurysm repair (EVAR) procedure.	Device Endoleak	4074	The observed device problem is persistent blood flow/pressure in the aneurysm sac following an endovascular aneurysm repair (EVAR) procedure. Where other device problems lead to an endoleak the observed problems should be coded and E2121 selected as the E term.	IMDRF:A050408
C	C54451	Medical Device Problem	C62872	Extracardiac stimulation Problem	Problem associated with undesired pacemaker induced stimulation of extracardiac (muscle) tissue (e.g. diaphragm, pectoral or intercostal muscle).	Extracardiac stimulation	1463	Problem associated with undesired pacemaker induced stimulation of extracardiac (muscle) tissue (e.g. diaphragm, pectoral or intercostal muscle)	IMDRF:A071209
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C73503	Hyperresponsive to stimuli	Higher perceptual capacity in one or more senses.	Hyperresponsive to stimuli	4538	Increased sensitivity affecting one or more senses	IMDRF:E0111
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C73504	Hyporesponsive to stimuli	Lower perceptual capacity in one or more senses.	Hyporesponsive to stimuli	2683	Decreased sensitivity affecting one or more senses	IMDRF:E0110
C	C54451	Medical Device Problem	C187251	Intravalvular Regurgitation	Problem associated with the escape or backward flow of blood through or across the valve.	Intravalvular regurgitation	4068	Problem associated with the escape or backward flow of blood through or across the valve. Also known as transvalvular regurgitation	IMDRF:A050406
C	C171094	Health Effects - Health Impact	C172008	Non-Serious Injury/Illness/Impairment	A mild injury, illness or impairment which can be treated with minimal or no intervention.	Non-Serious Injury/Illness/Impairment	4613	A non-serious injury, illness or impairment which can be treated with minimal or no intervention, including monitoring only.	IMDRF:F11
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50706	Pressure Sore	Death of tissue due to external pressure.	Pressure Sore/Ulcer	2326	Damage to tissue due as a result of external pressure.	IMDRF:E201401
C	C91801	Cause Investigation - Investigation Findings	C139521	Device Problem Related to Variant/Mutant	Device performance affected by variant/mutant which is not covered in the labelling.	Problem Related to Variant/Mutant	4236	Device performance affected by variant/mutant which is not covered in the labelling.	IMDRF:C1403
C	C91801	Cause Investigation - Investigation Findings	C92055	Device Separation Problem	Problems caused by the cut, tear, or fracture of a component, object, or material into two or more pieces including shear.	Separation Problem	3252	Problems caused by the cut, tear, or fracture of a component, object, or material into two or more pieces including shear.	IMDRF:C070603
C	C54451	Medical Device Problem	C193379	Unexpected Mode Switch	A device switches mode unexpectedly e.g. back-up mode or electrocautery mode.	Unexpected Mode Switch	4076	A device switches mode unexpectedly e.g. back-up mode or electrocautery mode.	IMDRF:A0723
C	C54451	Medical Device Problem	C63013	Activation, Positioning or Separation Problem	Problem associated with any deviations from the intended performance of the device that relate to the sequence of events for activation, positioning or separation of device.	Activation, Positioning or Separation Problem	2906	Problem associated with any deviations from the intended performance of the device that relate to the sequence of events for activation, positioning or separation of device. Note: Deployment is synonymous with activation.	IMDRF:A15
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C171950	Cardiovascular Dysfunction/Insufficiency	Circulatory dysfunction and/or insufficiency due to a decrease in the force of the cardiac contractions and/or the tone of the vascular walls.	Cardiovascular Dysfunction/Insufficiency	4445	Circulatory dysfunction/insufficiency due to a decrease in the force of the cardiac contractions and / or the tone of the vascular walls. Includes diastolic and systolic dysfunction.	IMDRF:E0607
C	C54451	Medical Device Problem	C63010	Device Difficult to Setup or Prepare	Problem associated with the user experiencing difficulty in preparing the device for use, even if the operation is being performed according to labeled instructions for use. This includes difficulty attaching or connecting parts together.	Device Difficult to Setup or Prepare	1487	Problem associated with the user experiencing difficulty in preparing the device for use, even if the operation is being performed according to labeled instructions for use. This includes difficulty attaching or connecting parts together.	IMDRF:A2201
C	C171094	Health Effects - Health Impact	C198673	Additional or Unexpected Endoscopic Procedure	The situation when a patient required an additional or unexpected endoscopic procedure.	Endoscopic Diagnostic Procedure	4638	Patient required additional or unexpected endoscopic diagnostic procedure.	IMDRF:F2202
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C187286	Eye Irritation	A generic term used to describe abnormal sensations that bother the eyes like dryness, itchiness, burning, grittiness and excessive blinking.	Eye Irritation	4803	A generic term used to describe abnormal sensations that bother the eyes like dryness, itchiness, burning, grittiness and excessive blinking.	IMDRF:E0845
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50417	Failure To Anastomose	Failure of a surgically-induced connection between tubular structures in the body.	Failure to Anastomose	1028	Failure of a surgically-induced connection between tubular structures in the body. Includes Anastomotic Leakage	IMDRF:E2108
C	C54577	Medical Device Component	C193447	Firmware	Computer instructions and data that reside as read-only software on that device. The computer cannot modify such software during processing.	Firmware	4777	Computer instructions and data that reside as read-only software on that device. The computer cannot modify such software during processing.	IMDRF:G0200804
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C34620	Foreign Body	Extraneous material within the body.	Foreign Body In Patient	2687	An occurrence involving any object including device and/or fragments of device being left unintentionally in the body. This includes devices left in the body as part of risk mitigation or surgical bailout procedures since their presence or location is not as originally intended.	IMDRF:E2008
C	C54451	Medical Device Problem	C76121	Human-Device Interface Issue	Problem associated with the user experiencing difficulty operating or otherwise interacting with the device, even if the operation is being performed according to labeled instructions for use.	Human-Device Interface Problem	2949	Problem associated with the user experiencing difficulty operating or otherwise interacting with the device, even if the operation is being performed according to labeled instructions for use.	IMDRF:A22
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50588	Hyperemia	The presence of an increased amount of blood in a part or organ; engorgement.	Hyperemia	1904	The presence of an increased amount of blood in a part or organ; engorgement or bloodshot	IMDRF:E2322
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C26800	Hypothyroidism	Abnormally low levels of thyroid hormone.	Hypothyroidism	4860	Abnormally low levels of thyroid hormone	IMDRF:E1212
C	C171094	Health Effects - Health Impact	C171994	Inadequate/Inappropriate Treatment or Diagnostic Exposure due to Device	Patient did not receive intended treatment from a device or received inadequate treatment as a consequence of device performance.	Inadequate/Inappropriate Treatment or Diagnostic Exposure	4610	Patient did not receive intended treatment from a device or received inadequate treatment as a consequence of device performance. This includes inadequate/inappropriate electrical stimulation or radiation dosage during procedures.	IMDRF:F10
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C78377	Intraoperative Cardiac Injury	Damage to the heart during a surgical procedure.	Intraoperative Cardiac Injury	4855	An intraoperative event that results in damage to, or abnormal function of, the heart. For valvular injury, use E0624 - Intraoperative Cardiac Valve Injury	IMDRF:E0627
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193390	Intraoperative Cardiac Valve Injury	An intraoperative event that causes abnormal valve function; this is usually a tear in the leaflet or the chordae tendinae.	Intraoperative Cardiac Valve Injury	4852	An intraoperative event that results in damage to, or abnormal function of, a heart valve. E.g. a tear in the leaflet or the chordae tendinae.	IMDRF:E0624
C	C54451	Medical Device Problem	C63058	Leak/Splash	Problem associated with the escape or ingress of a liquid (including blood and bodily fluids), gas or radiation from or into a vessel or container.	Leak/Splash	1354	Problem associated with the escape or ingress of a liquid (including blood and bodily fluids), gas or radiation from or into a vessel or container.	IMDRF:A0504
C	C54451	Medical Device Problem	C63041	Manufacturing, Packaging or Shipping Problem	Problem associated with any deviations from the intended performance of the device that appear to relate to the manufacturing, packaging or shipping processes.	Manufacturing, Packaging or Shipping Problem	2975	Problem associated with any deviations from the intended performance of the device that appear to relate to the manufacturing, packaging or shipping processes.	IMDRF:A02
C	C54451	Medical Device Problem	C62847	Material Too Rigid or Stiff	Problem associated with undesired rigidity of device material (resisting deformation in response to an applied force).	Material Too Rigid or Stiff	1544	Problem associated with undesired rigidity of device material (resisting deformation in response to an applied force).	IMDRF:A040607
C	C171094	Health Effects - Health Impact	C171940	Additional Medication Required	Patient required additional medication or additional dose of existing medication.	Medication Required	4644	Patient required new/additional medication or additional dose of existing medication.	IMDRF:F2303
C	C171094	Health Effects - Health Impact	C206541	Problem Identified Before Clinical Use/Exposure	The adverse event occurred during or immediately prior to a clinical procedure, but the problem was identified and corrected before harm could be caused.	Problem identified before clinical use/exposure	4656	The adverse event occurred during or immediately prior to a clinical procedure, but the problem was identified and corrected before harm could be caused. E.g.1. an IVD gave a false reading but it was recognized as incorrect before treatment decisions were made and without any clinically significant delay to diagnosis; E.g.2. a surgical device malfunctioned during pre-use checks and the malfunction was corrected or an alternative device was available without any clinically significant delay to the procedure.	IMDRF:F2601
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50717	Purulent Discharge	Pus-containing fluid that is draining from an orifice or wound.	Purulent Discharge	1812	A flow or draining of pus or exudate from an orifice or wound.	IMDRF:E231501
C	C54451	Medical Device Problem	C62844	Self-Activation or Keying	Problem associated with the unexpected or unintended activation of the device or a device function.	Self-Activation or Keying	1557	Problem associated with the unexpected or unintended activation of the device or a device function. For Unintended Power Up use A070804	IMDRF:A150104
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C26912	Vasculitis	An inflammatory process involving the wall of the vessels (large, medium, or small-sized vessels). The inflammatory process may cause necrosis or formation of granulomas in the vascular wall. It may be the result of an autoimmune disorder, infection, or malignancy. Representative examples include polyarteritis nodosa, temporal arteritis, Wegener granulomatosis, Kawasaki disease, Takayasu arteritis, and Henoch-Schonlein purpura.	Vasculitis	2004	Inflammation of any one of the blood vessels, including the arteries, veins, and rest of the vasculature system in the body.	IMDRF:E0512
C	C171094	Health Effects - Health Impact	C206543	Accidental Substance Exposure	Unintended exposure to a substance.	Accidental Exposure to Substance	4654	Unintended exposure of the patient and/or healthcare providers to drugs or other substances. This can include any exposure routes such as skin, mucous membranes, and respiratory.	IMDRF:F1008
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193465	Ambulation or Postural Difficulties	Any persistent problem with walking, gait or maintaining posture (sitting, standing).	Ambulation or Postural Difficulties	2544	Any persistent problem with walking, gait or maintaining posture (sitting, standing).	IMDRF:E2302
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C172078	Appropriate Clinical Signs, Symptoms, Conditions Term/Code Not Available	The clinical signs, symptoms and conditions are not adequately described by any other term.	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4581	The clinical signs, symptoms and conditions are not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:E2402
C	C54577	Medical Device Component	C171943	Appropriate Component Term/Code Not Available	The parts, components, or sub-assemblies are not adequately described by any other term.	Appropriate Component Term/Code Not Available	4756	The parts, components, or sub-assemblies are not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:G07002
C	C54451	Medical Device Problem	C64343	Appropriate Device Problem Term/Code Not Available	A device problem is not adequately described by any other term.	Appropriate Device Problem Term/Code Not Available	3191	The device problem is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:A27
C	C171094	Health Effects - Health Impact	C171944	Appropriate Health Impact Term/Code Not Available	There is no appropriate Health Impact term or code.	Appropriate Health Impact Term/Code Not Available	4650	The Health Impact is not adequately described by any other term. Note: this code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:F28
C	C91802	Cause Investigation - Investigation Conclusion	C139469	Appropriate Investigation Conclusion Term/Code Not Available	The concluded cause is not adequately described by any other term.	Appropriate Investigation Conclusion Term/Code Not Available	4316	The concluded cause is not adequately described by any other term. Note: This code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:D17
C	C91801	Cause Investigation - Investigation Findings	C139466	Appropriate Investigation Findings Term/Code Not Available	Problem is not adequately described by any other term.	Appropriate Investigation Findings Term/Code Not Available	4247	Problems is not adequately described by any other term. Note: This code must not be used unless there is no other feasible code. The preferred term should be documented when submitting an adverse event report. This information will be used to determine if a new term should be added to the code table.	IMDRF:C22
C	C91802	Cause Investigation - Investigation Conclusion	C139481	Cause Traced to Missing or Inadequate Safety Measures	Problems traced to inadequate design or complete lack of safety measures leading to device malfunction or unintended properties of the device including possible hazards for persons using the device.	Cause Traced to Missing or Inadequate Safety Measures	4305	Problems traced to inadequate design or complete lack of safety measures leading to device malfunction or unintended properties of the device including possible hazards for persons using the device.	IMDRF:D0105
C	C54451	Medical Device Problem	C63213	Electrostatic Discharge Problem	Problem associated with the discharge of electricity between two bodies previously electrically charged.	Electrostatic Discharge	2149	Problem associated with the discharge of electricity between two bodies previously electrically charged.	IMDRF:A0717
C	C91801	Cause Investigation - Investigation Findings	C92047	Electrostatic Discharge Identified	Problems due to sudden and momentary bursts of electrical current flowing between two objects at different electrical potentials.	Electrostatic Discharge Identified	648	Problems due to sudden and momentary bursts of electrical current flowing between two objects at different electrical potentials.	IMDRF:C0302
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50530	Diabetic Ketoacidosis	The metabolic condition resulted from uncontrolled diabetes mellitus, in which the shift of acid-base status of the body toward the acid side because of loss of base or retention of acids other than carbonic acid is accompanied by the accumulation of ketone bodies in body tissues and fluids.	Elevated ketones/Diabetic Ketoacidosis	2364	Elevated ketones, including metabolic acidosis produced by accumulation of ketone bodies resulting from uncontrolled diabetes mellitus.	IMDRF:E120501
C	C54451	Medical Device Problem	C172080	Imprecise or Erratic Results	Erroneous/discrepant results which combine high/low and/or positive/negative results.	Imprecise or Erratic Results	4059	Reports of erroneous/discrepant results which combine high/low and/or positive/negative results. This term is not to be selected where reports indicate consistently high or low or false positive or false negative results.	IMDRF:A090813
C	C54577	Medical Device Component	C187378	Insufficient Component Information to Classify Device	There is not yet enough information available to classify the medical device component.	Insufficient Component Information	4776	There is not yet enough information available to classify the medical device component.	IMDRF:G07003
C	C54451	Medical Device Problem	C172136	Insufficient Device Problem Information for Adverse Event	Not yet enough information available to classify the device problem from the adverse event.	Insufficient Device Problem Information	3190	An adverse event appears to have occurred but there is not yet enough information available to classify the device problem.	IMDRF:A26
C	C171094	Health Effects - Health Impact	C172138	Insufficient Information to Classify Health Impact	Not enough information available to classify the health impact.	Insufficient Health Impact Information	4648	It is not clear whether any health impact occurred, or health impact appears to have occurred, but there is not yet enough information available to classify the health impact.	IMDRF:F24
C	C91801	Cause Investigation - Investigation Findings	C92072	Loss of Power Identified 	A device that experienced problems due to a loss in the power supply.	Loss of Power Identified	610	A device that experienced problems due to a loss in the power supply.	IMDRF:C020702
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C78255	Device-Related Infection	Infection local to an implanted or invasive medical device.	Medical device site infection	4845	Infection local to an implanted or invasive medical device.	IMDRF:E2123
C	C91801	Cause Investigation - Investigation Findings	C139508	Missing or Inadequate Safety Measures Identified	Safety measures are inadequately applied or missing.	Missing or Inadequate Safety Measures Identified	4227	Safety measures are inadequately applied or missing.	IMDRF:C1208
C	C91801	Cause Investigation - Investigation Findings	C139509	Premature Indicator Activation Identified	A system intended to indicate the device status was triggered prematurely.	Premature Indicator Activation Identified	4224	A system intended to indicate the device status was triggered prematurely.	IMDRF:C1205
C	C171094	Health Effects - Health Impact	C50823	Prolonged Surgery	Surgery that is lengthy or that takes longer than anticipated.	Prolonged Surgery	4632	Surgery that takes longer than anticipated.	IMDRF:F1908
C	C91801	Cause Investigation - Investigation Findings	C92101	Radiofrequency Interference Identified	Problems due to radiofrequency interference. RFI is a disturbance that affects an electrical circuit due to either electromagnetic conduction or electromagnetic radiation emitted from an external source.	Radiofrequency Interference (RFI) Identified	611	Problems due to radiofrequency interference. RFI is a disturbance that affects an electrical circuit due to either electromagnetic conduction or electromagnetic radiation emitted from an external source.	IMDRF:C0305
C	C91801	Cause Investigation - Investigation Findings	C139512	Reset Problem Identified	The device does not reset properly.	Reset Problem Identified	4225	The device does not reset properly.	IMDRF:C1206
C	C91801	Cause Investigation - Investigation Findings	C139495	Unintended Compatibility Identified	The device was confirmed to be compatible with another device with which the device is intended to be incompatible.	Unintended Compatibility Identified	4207	The device was confirmed to be compatible with another device with which the device is intended to be incompatible.	IMDRF:C0404
C	C54451	Medical Device Problem	C63264	Use of Incorrect Control/Treatment Settings	Problem associated with the use of the device in terms of inappropriate or incorrect control settings or incorrect treatment parameters for the device's specified operation and/or intended use.	Use of Incorrect Control/Treatment Settings	1126	Problem associated with the use of the device in terms of inappropriate or incorrect control settings or incorrect treatment parameters for the device's specified operation and/or intended use.	IMDRF:A2302
C	C91801	Cause Investigation - Investigation Findings	C92132	Wireless Communication Problem Identified	Communications problems between devices within a wireless system.	Wireless Communication Problem Identified	3248	Communications problems between devices within a wireless system.	IMDRF:C040102
C	C171094	Health Effects - Health Impact	C15189	Biopsy Procedure	The removal of tissue specimens or fluid from the living body for microscopic examination, performed to establish a diagnosis.	Biopsy	4637	Patient required removal of tissue or fluid specimen to establish a diagnosis.	IMDRF:F2201
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C113451	Have Increased Appetite Question	A question about whether an individual has or had increased appetite.	Increased Appetite	4570	Intense desire for food.	IMDRF:E2307