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
Low Battery	10	10
Battery Problem	10	10
Break	10	10
Charging Problem	8	8
Low impedance	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
Device Difficult to Program or Calibrate	3	3
Material Deformation	3	3
Therapy Delivered to Incorrect Body Area	2	2
Connection Problem	2	2
Pocket Stimulation	2	2
Overheating of Device	2	2
Appropriate Term/Code Not Available	2	2
Failure to Power Up	2	2
Patient Device Interaction Problem	2	2
Unstable	2	2
Loss of Data	1	1
Device Damaged by Another Device	1	1
Impedance Problem	1	1
Output Problem	1	1
Material Integrity Problem	1	1
Positioning Problem	1	1
Disconnection	1	1
Nonstandard Device	1	1
Human-Device Interface Problem	1	1
Electromagnetic Interference	1	1
No Device Output	1	1
Energy Output To Patient Tissue Incorrect	1	1
Unintended Collision	1	1
Noise, Audible	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