TPLC - Total Product Life Cycle

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Device	stimulator, brain, implanted, for behavior modification
Product Code	MFR
Device Class	Humanitarian Device Exemption

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	86	86
Device Operates Differently Than Expected	30	30
High impedance	24	24
Device Displays Incorrect Message	14	14
Failure to Deliver Energy	13	13
Intermittent Continuity	12	12
Migration or Expulsion of Device	11	11
Battery Problem	10	10
Break	10	10
Low Battery	10	10
Low impedance	8	8
Charging Problem	8	8
Electromagnetic Compatibility Problem	7	7
Malposition of Device	6	6
Communication or Transmission Problem	6	6
Premature Discharge of Battery	6	6
Inappropriate/Inadequate Shock/Stimulation	5	5
Delayed Charge Time	4	4
Improper or Incorrect Procedure or Method	4	4
Insufficient Information	3	3
Material Deformation	3	3
Device Difficult to Program or Calibrate	3	3
Appropriate Term/Code Not Available	2	2
Overheating of Device	2	2
Connection Problem	2	2
Pocket Stimulation	2	2
Therapy Delivered to Incorrect Body Area	2	2
Patient Device Interaction Problem	2	2
Unstable	2	2
Failure to Power Up	2	2
Output Problem	1	1
Material Integrity Problem	1	1
Positioning Problem	1	1
Disconnection	1	1
Loss of Data	1	1
Energy Output To Patient Tissue Incorrect	1	1
Electromagnetic Interference	1	1
Nonstandard Device	1	1
Human-Device Interface Problem	1	1
Noise, Audible	1	1
Unintended Collision	1	1
No Device Output	1	1
Impedance Problem	1	1
Device Damaged by Another Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	44	44
Cognitive Changes	41	41
Therapeutic Effects, Unexpected	35	35
Complaint, Ill-Defined	34	34
Depression	24	24
Therapeutic Response, Decreased	23	23
Unspecified Infection	19	19
Anxiety	16	16
Emotional Changes	13	13
Headache	9	9
Dysphasia	8	8
Pain	8	8
Fracture, Arm	7	7
Insufficient Information	7	7
Bone Fracture(s)	7	7
Erythema	6	6
Inflammation	6	6
Sleep Dysfunction	5	5
Electric Shock	5	5
Distress	4	4
Seizures, Focal	4	4
No Clinical Signs, Symptoms or Conditions	4	4
Nausea	4	4
Seizures	4	4
Apnea	3	3
Undesired Nerve Stimulation	3	3
Twiddlers Syndrome	3	3
Dyskinesia	3	3
Fatigue	3	3
Vertigo	3	3
Swelling	3	3
No Code Available	3	3
Muscular Rigidity	3	3
Seizures, Absence	3	3
Weight Changes	2	2
Irritability	2	2
Loss of consciousness	2	2
Death	2	2
Bacterial Infection	2	2
Hypersensitivity/Allergic reaction	2	2
Tingling	2	2
Abscess	2	2
Paresis	2	2
Hemorrhage, Cerebral	2	2
Muscle Spasm(s)	2	2
Burning Sensation	2	2
Visual Disturbances	2	2
Intracranial Hemorrhage	2	2
Memory Loss/Impairment	2	2
Seizures, Grand-Mal	2	2