TPLC - Total Product Life Cycle

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Device	intestinal stimulator
Product Code	LNQ
Device Class	Humanitarian Device Exemption

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Device Problem Information	286	286
Adverse Event Without Identified Device or Use Problem	266	266
Inappropriate/Inadequate Shock/Stimulation	101	101
Battery Problem	72	72
Migration or Expulsion of Device	65	65
High impedance	59	59
Break	45	45
Electromagnetic Compatibility Problem	30	30
Premature Discharge of Battery	29	29
Impedance Problem	28	28
Patient Device Interaction Problem	25	25
Unintended Electrical Shock	21	21
Malposition of Device	20	20
Unstable	19	19
Appropriate Device Problem Term/Code Not Available	18	18
Energy Output Problem	14	14
Migration	13	13
Failure to Deliver Energy	12	12
Electromagnetic Interference	10	10
No Apparent Adverse Event	10	10
Entrapment of Device	9	9
Intermittent Continuity	9	9
Material Deformation	8	8
Positioning Problem	8	8
Connection Problem	7	7
Extracardiac stimulation	7	7
Disconnection	6	6
Communication or Transmission Problem	6	6
Failure to Interrogate	6	6
Lack of Effect	5	5
Therapy Delivered to Incorrect Body Area	4	4
Intermittent Shock/Stimulation	4	4
Improper or Incorrect Procedure or Method	4	4
Patient-Device Incompatibility	4	4
Unintended Collision	3	3
Loose or Intermittent Connection	3	3
Overheating of Device	3	3
Device Dislodged or Dislocated	3	3
Low impedance	3	3
Material Puncture/Hole	3	3
Data Problem	3	3
Environmental Compatibility Problem	3	3
Vibration	3	3
Material Twisted/Bent	3	3
Defective Device	3	3
Unintended Movement	2	2
Misassembly by Users	2	2
Device Contamination with Chemical or Other Material	2	2
Material Erosion	2	2
Material Perforation	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	211	211
Insufficient Information	183	183
Electric Shock	174	174
Failure of Implant	139	139
Pain	99	99
Nausea	88	88
Vomiting	83	83
Unspecified Infection	78	78
Abdominal Pain	34	34
Implant Pain	27	27
Discomfort	24	24
Erosion	18	18
Pocket Erosion	16	16
Unspecified Gastrointestinal Problem	16	16
Weight Changes	15	15
Malaise	14	14
Internal Organ Perforation	14	14
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Obstruction/Occlusion	10	10
Undesired Nerve Stimulation	9	9
Seroma	9	9
Paresis	9	9
Diarrhea	9	9
Cramp(s) /Muscle Spasm(s)	8	8
Swelling/ Edema	7	7
Medical device site infection	7	7
Erythema	7	7
Scar Tissue	7	7
Burning Sensation	7	7
Abdominal Distention	7	7
Sepsis	6	6
Twiddlers Syndrome	6	6
Skin Infection	5	5
Constipation	5	5
Fluid Discharge	5	5
Shaking/Tremors	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
Hypersensitivity/Allergic reaction	3	3
Hematoma	3	3
Foreign Body Reaction	3	3
Dehydration	3	3
Adhesion(s)	3	3
Post Operative Wound Infection	3	3
Shock	3	3
Impaired Healing	3	3
Device Embedded In Tissue or Plaque	3	3
External Prosthetic Device Pain	2	2
Urinary Frequency / Polyuria	2	2
Twitching	2	2
Wound Infection	2	2