TPLC - Total Product Life Cycle

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Device	stimulator, peripheral nerve, implanted (pain relief)
Product Code	GZF
Regulation Number	882.5870
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	859	859
Migration	205	205
Use of Device Problem	148	148
Insufficient Information	96	96
Migration or Expulsion of Device	60	60
Appropriate Term/Code Not Available	42	42
Intermittent Communication Failure	34	34
Malposition of Device	34	34
Device Unsafe to Use in Environment	34	34
Fracture	28	28
Off-Label Use	28	28
Improper or Incorrect Procedure or Method	26	26
Material Erosion	25	25
Expulsion	16	16
Material Protrusion/Extrusion	14	14
Inappropriate/Inadequate Shock/Stimulation	12	12
Patient-Device Incompatibility	10	10
Impedance Problem	10	10
Patient Device Interaction Problem	8	8
Detachment of Device or Device Component	7	7
Lack of Effect	7	7
Battery Problem	7	7
Therapeutic or Diagnostic Output Failure	7	7
High impedance	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Break	5	5
Unintended Electrical Shock	4	4
No Apparent Adverse Event	4	4
Temperature Problem	3	3
Device-Device Incompatibility	3	3
Microbial Contamination of Device	2	2
Fluid/Blood Leak	2	2
Circuit Failure	2	2
Overheating of Device	2	2
Device Appears to Trigger Rejection	2	2
Pocket Stimulation	2	2
Physical Resistance/Sticking	2	2
Communication or Transmission Problem	2	2
Biocompatibility	1	1
Therapy Delivered to Incorrect Body Area	1	1
Electrical /Electronic Property Problem	1	1
Inadequate or Insufficient Training	1	1
Nonstandard Device	1	1
Sparking	1	1
Power Problem	1	1
Device Dislodged or Dislocated	1	1
Failure to Conduct	1	1
Defibrillation/Stimulation Problem	1	1
Material Separation	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inadequate Pain Relief	357	357
Pain	213	213
Post Operative Wound Infection	202	202
Erosion	165	165
No Clinical Signs, Symptoms or Conditions	141	141
Impaired Healing	125	125
Skin Infection	119	119
Skin Inflammation/ Irritation	102	102
Electric Shock	80	80
Swelling/ Edema	61	61
Unspecified Infection	53	53
Discomfort	52	52
Burning Sensation	49	49
Wound Dehiscence	34	34
Skin Erosion	32	32
Insufficient Information	30	30
Purulent Discharge	27	27
Erythema	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Fluid Discharge	17	17
Cellulitis	16	16
Implant Pain	15	15
Skin Irritation	14	14
Blister	13	13
Pocket Erosion	12	12
Hemorrhage/Bleeding	12	12
Bacterial Infection	12	12
Numbness	10	10
Rash	7	7
Failure of Implant	7	7
Hypersensitivity/Allergic reaction	7	7
Shock from Patient Lead(s)	6	6
Drug Resistant Bacterial Infection	6	6
Itching Sensation	5	5
Stroke/CVA	5	5
Fever	5	5
Hematoma	4	4
Abscess	4	4
Dizziness	4	4
Bruise/Contusion	4	4
Cardiac Arrest	3	3
Burn(s)	3	3
Urinary Tract Infection	3	3
Skin Tears	2	2
Myocardial Infarction	2	2
Tissue Damage	2	2
Scar Tissue	2	2
Loss of consciousness	2	2
Granuloma	2	2
Swelling	2	2