D	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C187373	Peri-prosthetic Joint Infection	Infection around an implant following joint replacement.	Peri-prosthetic Joint Infection	4845	Infection around an implant following joint replacement.	IMDRF:E2123
D	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C38003	Phlebitis	Inflammation of a vein.	Phlebitis	2004	Inflammation of a vein.	IMDRF:E0512
D	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50680	Ossification	The formation of bone or of a bony substance; the conversion of fibrous tissue or of cartilage into bone or a bony substance.	Ossification	1428	The formation of bone or of a bony substance; the conversion of fibrous tissue or of cartilage into bone or a bony substance.	IMDRF:E1626
D	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C78583	Rectal Anastomotic Leakage	Leakage due to breakdown of a rectal anastomosis.	Rectal Anastomotic Leakage	4482	Leakage due to breakdown of a rectal anastomosis.	IMDRF:E1026
D	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C78718	Wheezing	A symptom and a finding during physical examination, characterized by a high-pitched, whistling sound during breathing. It results from the narrowing or obstruction of the respiratory airways. The most common causes of wheezing are asthma, chronic obstructive pulmonary disease, tracheobronchitis, and pulmonary edema.	Wheezing	4463	A symptom and finding during physical examination, characterized by high-pitched, whistling sound during breathing. it results from narrowing or obstruction of the respiratory airways.	IMDRF:E0751
D	C54577	Medical Device Component	C49880	Helifix Coil Device	A coil designed to allow a Helifix pacing electrode to be placed in the endocardium.	Helifix Coil	567	A coil designed to allow a Helifix pacing electrode to be placed in the endocardium.	IMDRF:G0403001
A	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
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C78500	Nasal Congestion	The blockage of the nasal passage due to mucosal edema. It is usually the result of a viral infection or an allergic reaction.	Nasal congestion	4874	The blockage of the nasal passage due to mucosal edema. It is usually the result of a viral infection or an allergic reaction.	IMDRF:E0756
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C79748	Atrophy	Any weakening or degeneration, especially through lack of use.	Atrophy	4913	Decrease in size of a body part, cell, organ, or other tissue. For muscular atrophy use E1621 - Muscle Weakness/Atrophy	IMDRF:E2351
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C95556	Nail Changes	Alteration of the normal characteristics of the fingernails or toenails. Examples include thickening, thinning, deformity, and separation from the nail bed.	Nail disorder	4897	Abnormality of the nail, such as problems with the color, shape, texture, or thickness of the fingernails or toenails.	IMDRF:E1728
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C99064	Spinal Deformity	A congenital or acquired deformity of the spine. Representative examples include scoliosis, kyphosis, and sagittal imbalance.	Spinal deformity	4886	Abnormal curvature and/or alignment of the spine.	IMDRF:E1642
A	C54451	Medical Device Problem	C206562	Implant Subsidence	Problem related to the settling or collapse of bone adjacent to an implanted device.	Implant subsidence	4078	Problem related to the settling or collapse of bone adjacent to an implanted device, in direction of the loading force.	IMDRF:A0107
A	C54451	Medical Device Problem	C206563	Device Packaging Look-Alike	Problem associated with medical device packaging that looks similar to another product.	Device packaging look-alike	4079	Problem associated with medical device packaging that looks similar to another product leading to confusion. The other product may be another device or a different product such as a medicine or cleaning agent. Use A210107 for Device label look-alike.	IMDRF:A020505
A	C54451	Medical Device Problem	C206564	Device Provides Uninformative Message	The device provides a message which is unhelpful or uninformative.	Device Provides Uninformative Message	4082	The device provides a message which is unhelpful or uninformative, such as an error code without further information about the meaning or appropriate action to take. If the message does not make sense then use A2206 - Device Provides Unintelligible Message.	IMDRF:A2205
A	C54451	Medical Device Problem	C206565	Device Provides Unintelligible Message	The device provides an unintelligible or incomprehensible message such as an apparently random string of characters.	Device Provides Unintelligible Message	4083	The device provides an unintelligible or incomprehensible message such as an apparently random string of characters. If the message makes sense but is not helpful then use A2205 - Device Provides Uninformative Message.	IMDRF:A2206
A	C54451	Medical Device Problem	C206566	Device Label Look-Alike	Problem associated with medical device label that looks similar to another product labeling.	Device label look-alike	4081	Problem associated with medical device label that looks similar to another product leading to confusion. The other product may be another device or a different product such as a medicine or cleaning agent. Use A020505 for Device packaging look-alike.	IMDRF:A210107
A	C54451	Medical Device Problem	C50797	Valvular Regurgitation	Regurgitation of the blood of the heart valves owning to imperfect closing, insufficiency or incompetency of the valves.	Unspecified Valve Regurgitation	4080	Problem associated with the escape or backward flow of blood relative to a valve where it is not specified or not confirmed whether the leak is transvalvular/intravalvular or paravalvular/perivalvular.	IMDRF:A050409
A	C54577	Medical Device Component	C206557	Fixation Tines	Projections designed to fix a device inside an anatomic space.	Fixation Tines	4781	Projections designed to fix a device inside a cavity of the human body	IMDRF:G0400501
A	C54577	Medical Device Component	C206676	Fixation Helix	A coil designed for fixing or anchoring a device in human tissue.	Fixation Helix	567	A coil designed for fixing or anchoring a device in human tissue.	IMDRF:G0403001
A	C91801	Cause Investigation - Investigation Findings	C206561	Device Misadjustment/Misalignment Identified	Problems caused by incorrect adjustment/alignment of device components.	Misadjustment/misalignment identified	4257	Problems caused by incorrect adjustment of device components.	IMDRF:C1701
A	C91802	Cause Investigation - Investigation Conclusion	C206571	Unable to Exclude Device Problem	The investigation findings do not clearly confirm the presence or absence of the reported problem with the device.	Unable to exclude device problem	4322	The investigation findings do not clearly confirm the presence or absence of the reported problem with the device.	IMDRF:D1401
A	C91802	Cause Investigation - Investigation Conclusion	C206572	Device Problem Excluded	The investigation findings clearly confirm that there was no problem with the device.	Device problem excluded	4323	The investigation findings clearly confirm that there was no problem with the device.	IMDRF:D1402
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C61043	Voice Alteration	Change in the sound and/or speed of the voice. Causes include laryngeal polyp, laryngitis, laryngeal carcinoma, throat carcinoma, Parkinson's disease, multiple sclerosis, stroke, hypothyroidism, oral surgery, tracheostomy, tracheal injury, and laryngeal injury.	Voice alteration	4906	Changes in the pitch or quality of the voice, which may sound weak, scratchy, raspy, or otherwise out of the ordinary.	IMDRF:E2344
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C75570	Graft Failure	Failure of transplanted tissue to become functional or operational, often as a result of destruction by the host's immune system.	Graft failure	4905	Failure of a transplanted graft.	IMDRF:E2130
A	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
A	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
A	C171094	Health Effects - Health Impact	C206555	Non-Surgical Treatment under Anesthesia	Patient required non-surgical treatment under anesthesia.	Medical treatment under anaesthesia	4655	Patient required non-surgical treatment under anaesthesia.	IMDRF:F2308
A	C171094	Health Effects - Health Impact	C206569	Death Not Related to Adverse Event	A death has occurred, but it was confirmed that the event did not contribute to the death.	Death not related to reported adverse event	4657	A death has occurred, but it was confirmed that the event did not contribute to the death. Other terms may also be selected if it is possible to link the adverse event to other identifiable health impacts.	IMDRF:F29
A	C171094	Health Effects - Health Impact	C206675	Problem Identified during Non-Clinical Procedure	An adverse event occurred while a device was being used in a non-clinical setting and/or procedure and could not have any impact on a patient.	Problem identified during non-clinical procedure	2645	The adverse event occurred while the device was being used in a non-clinical setting and/or procedure and could not have any impact on a patient. E.g.1. an IVD gave a false reading when testing an External Quality Assessment (EQA) sample; E.g.2. a surgical device malfunctioned during cleaning and/or maintenance.	IMDRF:F27
A	C171094	Health Effects - Health Impact	C50421	Surgical Procedure Stopped	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
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C118422	Compartment Syndrome	Elevated pressure in a confined space enclosed by fascia or eschar, which may lead to vascular compromise and subsequent ischemic injury to the tissue within the space.	Compartment syndrome	4888	Condition in which a closed muscle compartment's pressure increases to such an extent that the circulation is diminished, e.g. due to decrease in a compartment volume or an increase in the contents of a compartment, or both.	IMDRF:E1644
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C121573	Crepitus	Air trapped in the subcutaneous space. It can be palpated or heard as a crackling or grating sensation under the skin.	Crepitus	4893	Grating sound or sensation produced by friction between e.g. bone, cartilage, fractured parts of a bone.	IMDRF:E1649
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C148023	Sleep-Disordered Breathing	A group of breathing disorders characterized by abnormal respiratory patterns or insufficient ventilation during sleep.	Breathing-related sleep disorder	4875	Clinical spectrum with frequent episodes of either complete or partial obstruction of the upper airway during sleep. Includes sleep apnea. Also known as Sleep disordered breathing (SDB).	IMDRF:E0757
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206535	Abnormal Mucus Discharge	Any deviation from the normal quantity, consistency, and/or color of mucus produced by the mucous membranes.	Abnormal mucus discharge	4910	Any deviation from the normal quantity, consistency, and/or color of mucus produced by the mucous membranes.	IMDRF:E2348
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206536	Bone Notch	An indentation at the edge of the bone without bone breakage.	Bone Notching	4890	An indentation made at the edge of the bone without bone breakage.	IMDRF:E1646
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206537	Joint Locking	Joint is unable to move freely.	Joint locking	2672	Joint is blocked or becomes stuck. For Pseudo-locking use E1616 - Loss of Range of Motion.	IMDRF:E161605
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206538	Loss of Fracture Reduction	Loss of anatomical alignment after fracture reduction.	Loss of fracture reduction	4901	Loss of anatomical alignment after fracture reduction.	IMDRF:E2126
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206539	Aseptic Loosening	Failure of the fixation of a prosthetic component in the absence of infection.	Aseptic loosening	4883	Failure of the fixation of a prosthetic component in the absence of infection.	IMDRF:E161201
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206540	Prosthesis Septic Loosening	Failure of the fixation of a prosthetic component in the presence of infection.	Septic loosening	4884	Failure of the fixation of a prosthetic component in the presence of infection.	IMDRF:E161202
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206542	Abnormal Peritoneal Effluent	A change in the appearance characteristics of peritoneal dialysis effluent.	Peritoneal effluent abnormal	4904	A change in the appearance or other characteristics of peritoneal dialysis effluent (e.g. cloudy or discolored).	IMDRF:E2129
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206544	Tendinopathy	A disorder of the tendons with signs/symptoms of pain, diffuse or localized swelling and impaired performance.	Tendinopathy	4887	Overuse tendon injuries characterized by a combination of pain, diffuse or localized swelling, and impaired performance. Problems include tendonitis/tendinitis and tendinosis, as well as tendon tears and inflammation of membranes around a tendon	IMDRF:E1643
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206545	Fat Embolism	The blockage of a blood vessel by fat particles in the circulation.	Fat embolism	4869	The blockage of a blood vessel by fat particles in the circulation.	IMDRF:E050305
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206546	Bladder Dysfunction	Impaired or abnormal functioning of the bladder.	Bladder Dysfunction	4881	Impaired or abnormal functioning of the bladder, including sphincters.	IMDRF:E1316
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206547	Complex Regional Pain Syndrome	Condition where a person experiences persistent severe and debilitating pain, involving an extremity or other body region, hyperesthesia, and localized autonomic dysfunction following injury to soft tissue or nerve.	Complex regional pain syndrome	4899	Condition where a person experiences persistent severe and debilitating pain, involving an extremity or other body region, hyperesthesia, and localized autonomic dysfunction following injury to soft tissue or nerve	IMDRF:E2125
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206548	Periprosthetic Fracture	Fractures around joint replacement prosthetics or implants.	Periprosthetic fracture	4902	Fractures around joint replacement prosthetics or implants. These can occur intraoperatively or postoperatively.	IMDRF:E2127
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206549	Choroidal Detachment	A detachment of the choroid from the sclera often due to the accumulation of fluid (blood for hemorrhagic, other fluids for serous detachment) in the suprachoroidal space.	Choroidal detachment	4877	A detachment of the choroid from the underlying sclera often due to the accumulation of fluid (blood for hemorrhagic, other fluids for serous detachment) in the suprachoroidal space	IMDRF:E0858
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206550	Choroidal Effusion	Fluid accumulation in the suprachoroidal space.	Choroidal effusion	4878	Fluid accumulation in the suprachoroidal space, can lead to detachment	IMDRF:E0859
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206551	Coronary Obstruction/Occlusion	Partial or total occlusion or obstruction of the coronary ostia or artery.	Coronary obstruction/occlusion	4871	Partial or total occlusion or obstruction of the coronary ostia or artery.	IMDRF:E0521
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206552	Hemarthrosis	Bleeding into a joint.	Hemarthrosis	4889	Bleeding into the joints	IMDRF:E1645
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206553	Arthrofibrosis	Fibrotic joint disorder characterized by excessive collagen production and adhesions that result in restricted joint motion and pain.	Arthrofibrosis	4885	Fibrotic joint disorder characterized by excessive collagen production and adhesions that result in restricted joint motion and pain.	IMDRF:E161604
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206554	Unusual Breath Odor	A breath odor that is not normal for the individual.	Breath odor	4909	Unusual breath odor (e.g., halitosis, fruity/sweet breath)	IMDRF:E2347
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206556	Heat-Related Illness	A set of symptoms brought on by exposure to heat that can include confusion, hot dry skin, seizures, elevated body temperature, altered mental status.	Heat illness	4907	A set of symptoms brought on by exposure to heat that can include confusion, hot dry skin, seizures, elevated body temperature, altered mental status, etc. Includes heat stroke and heat exhaustion.	IMDRF:E2345
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206558	Dura Mater Tear	Injury to the dura mater, with or without damage to any other layer of the meninges.	Dural Tear	1417	Injury to the dura mater, with or without damage to any other layer of the meninges.	IMDRF:E0144
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206559	Non-Skin Tissue Irritation	Irritation of body tissue(s), other than skin.	Tissue Irritation	4912	Irritation of body tissue(s), other than skin. For skin irritation use E1720 - Skin Inflammation/Irritation	IMDRF:E2350
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206560	Upper Respiratory Tract Irritation	Irritation and swelling of the upper airways.	Upper Respiratory Tract Irritation	4872	Irritation and swelling of the upper airways	IMDRF:E0754
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206567	Implant Site Sclerosis	Pathological process consisting of hardening/thickening of tissue or structures at the site of an implant.	Implant site sclerosis	4903	Pathological process consisting of hardening/thickening of tissue or structures.	IMDRF:E2128
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206568	Acetabular Protrusion	Acetabular defect with a shift of the femoral head through the pelvis.	Acetabular protrusion	4892	Acetabular defect with a shift of the femoral head through the pelvic bone.	IMDRF:E1648
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206570	Perineal Injury	Traumatic damage and/or injury to the perineum.	Perineal injury	4898	Traumatic damage and/or injury to the perineum.	IMDRF:E2016
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206672	Wheezing/Stridor	A high pitched breathing sound that results from restricted airways.	Wheezing	4463	A symptom and finding during physical examination, characterized by high-pitched, whistling sound during breathing. It results from narrowing or obstruction of the respiratory airways. Also known as stridor.	IMDRF:E0751
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C206674	Extraskeletal Ossification	The formation of bone or of a bony substance outside the normal skeleton.	Extraskeletal ossification	1428	The formation of bone or of a bony substance outside the normal skeleton. Includes ectopic or heterotopic ossification, myositis ossificans.	IMDRF:E1626
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C26723	Colitis	Inflammation of the colon.	Colitis	4879	Inflammation of the large intestine	IMDRF:E1036
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C26796	Hydronephrosis	Dilation of the urinary collecting space in the kidney.	Hydronephrosis	4880	A condition of excess urine accumulation in kidney(s) that causes swelling of kidneys.	IMDRF:E1315
A	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		IMDRF:E0512
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C27549	Reactive Cutaneous Fibrous Lesion	A benign, epidermal skin lesion characterized by overexpression of collagen during wound healing.	Abnormal scarring	4896	Excessive or unusual scarring related to impaired wound healing (e.g. Keloid or Hypertrophic scar)	IMDRF:E171501
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C3029	Exostosis	Non-neoplastic overgrowth of bone.	Exostosis (bone)	4891	Benign hypertrophy that projects outward from the surface of bone, often containing a cartilaginous component, such as bone spurs/osteophytes.	IMDRF:E1647
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C34986	Rhinitis	An inflammation of the mucous membrane lining the nose, usually associated with nasal discharge.	Rhinitis	4876	Pattern of symptoms as a result of nasal inflammation and/or dysfunction of the nasal mucosa. There are various subtypes, such as allergic, infectious and non-allergic (e.g. atrophic) rhinitis.	IMDRF:E0758
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C35046	Substance Withdrawal Syndrome	A substance-specific organic brain syndrome that follows the discontinuation of administration or use, or reduction in intake of an addictive substance, e.g. opioids, barbiturates and alcohol; amphetamines or similarly acting sympathomimetics; cocaine; nicotine; sedatives, hypnotics, or anxiolytics. Syndrome manifests with diverse, often painful physical and psychological symptoms, which include but not limited to intense drug craving, anxiety, depression, insomnia, nausea, perspiration, body aches, tremors, hallucinations, and convulsions.	Withdrawal Syndrome	4911	The substance-specific organic brain syndrome that follows the discontinuation of, or reduction in, administration or intake of an addictive substance.	IMDRF:E2349
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C35245	Injury to Kidney	Trauma to the kidney.	Kidney injury	4882	Traumatic damage to the kidney(s).	IMDRF:E1317
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C35760	Arthropathy	Any disorder of the joints.	Arthropathy	4894	Diseases and disorders of a joint (e.g. Rotator cuff arthropathy, cuff tear arthropathy (CTA)) More specific codes and terms should be used where they exist e.g. E1602 - Arthritis	IMDRF:E1650
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C41830	Back Pain	Painful sensation in the back region.	Back pain	4895	Pain in any part of the back.	IMDRF:E1651
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50461	Aortic Dissection	A progressive tear in the tissue lining the aorta, characterized by the passage of blood from the tunica intima into, and partially through, the tunica media.	Aortic dissection	4870	Spontaneous or induced tear within the wall of the aorta	IMDRF:E051501
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C3124	Hypertrophy	Abnormal enlargement of a body part or organ.	Hypertrophy	4908	An increase in organ size via increase in cell size rather than cell number	IMDRF:E2346
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	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	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50487	Cerebrospinal Fluid Leakage	The loss of cerebrospinal fluid.	Cerebrospinal Fluid Leakage	1772	The loss of cerebrospinal fluid into the surrounding tissues or outside the body.	IMDRF:E0106
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50601	Impaired Healing	Improper body tissue repair due to factors affecting one or more of the phases of wound healing.	Impaired Healing	2378	Improper repair of any body tissue due to factors affecting one or more of the phases of wound healing. Includes impaired healing of any body tissue.	IMDRF:E1707
C	C54451	Medical Device Problem	C63194	Loss of or Failure to Bond	Problem associated with lack or loss of adherence between materials intended to be joined together by bonding.	Loss of or Failure to Bond	1068	Problem associated with lack or loss of adherence between materials intended to be joined together by any bonding such as an adhesive, heat welding, etc.	IMDRF:A040102
C	C91802	Cause Investigation - Investigation Conclusion	C91894	No Problem Detected	Problem not confirmed or confirmation of no problem.	No Problem Detected	67	Either it was not confirmed that there was a problem with the device, or it was confirmed that there was no problem with the device.	IMDRF:D14
C	C91802	Cause Investigation - Investigation Conclusion	C92099	Quality Control Deficiency	Problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications identified by the manufacturer. Includes inadequacy of components or raw materials supplied to the manufacturer.	Quality Control Deficiency	143	Problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications identified by the manufacturer. Includes inadequacy of components or raw materials supplied to the manufacturer.	IMDRF:D0302
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	C54451	Medical Device Problem	C63147	False Positive Result	Problem associated with the device incorrectly reporting that something has been detected and may mislead the operator to take certain actions.	False Positive Result	1227	Problem associated with the device incorrectly reporting that something has been detected and may mislead the operator/user/HCP to take certain actions.	IMDRF:A090804
C	C54451	Medical Device Problem	C63149	False Negative Result	Problem associated with the device incorrectly reporting that something has not been detected and may mislead the operator into not taking certain actions when action should be taken.	False Negative Result	1225	Problem associated with the device incorrectly reporting that something has not been detected and may mislead the operator/user/HCP into not taking certain actions when action should be taken.	IMDRF:A090803
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C78253	Depressed Level Of Consciousness	A neurologic state characterized by decreased ability to perceive and respond.	Decreased Level of Consciousness	4591	A neurological state characterised by decreased ability to perceive and respond.	IMDRF:E014302
C	C171094	Health Effects - Health Impact	C171956	Change in Therapeutic Response	Change in response to treatment or cure of a disease.	Change in Therapeutic Response	4601	Change in response to treatment or cure of a disorder or disease.	IMDRF:F01
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50552	Epiphora	Excessive tearing of the eyes due to either tear overproduction or impaired drainage of the tear ducts. Causes of tear overproduction include eye irritation (e.g., eye infection, foreign body in the eye), headache, pain reaction, allergies, sinusitis, and injury to the eye.	Excessive Tear Production	2235	Profuse lacrimation.	IMDRF:E0817
C	C54451	Medical Device Problem	C187253	Failure to Seal	Problem associated with the device failing to seal the intended vessel with the device intended to provide a seal.	Failure to Seal	4070	Problem associated with the device failing to seal the intended vessel with the device intended to provide a seal (e.g. electrosurgical hemostasis).	IMDRF:A050705
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C26769	Facial Nerve Paralysis	Partial or complete paralysis of the facial muscles of one side of a person's face. It is caused by damage to the seventh cranial nerve. It is usually temporary but it may recur.	Facial Paralysis	4585	A partial or complete loss of function of one or more of the facial muscles resulting in paralysis of the facial regions. Includes both central and peripheral facial paralysis or palsy.	IMDRF:E012209
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C34851	Increased Non-Protein Nitrogen	A laboratory test result indicating abnormally high concentration of non-protein nitrogen in the blood.	Uremia	2188	Abnormally high concentration of non-protein nitrogen in the blood.	IMDRF:E1306
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50841	Laceration of Esophagus	A torn, ragged, mangled wound, or an accidental cut of esophagus.	Laceration(s) of Esophagus	2398	A torn, ragged, mangled wound, or an accidental cut of esophagus.	IMDRF:E1018
C	C54451	Medical Device Problem	C63209	Environmental Compatibility Problem	Problem associated with the surrounding conditions in which the device is being used such as temperature, noise, lighting, ventilation, or other external factors such as power supply.	Environmental Compatibility Problem	2929	Problem associated with the surrounding conditions in which the device is being used such as temperature, noise, lighting, ventilation, or other external factors such as power supply.	IMDRF:A19