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	876	876
Migration	189	189
Use of Device Problem	125	125
Insufficient Information	89	89
Migration or Expulsion of Device	60	60
Appropriate Term/Code Not Available	40	40
Malposition of Device	33	33
Device Unsafe to Use in Environment	29	29
Improper or Incorrect Procedure or Method	27	27
Intermittent Communication Failure	26	26
Off-Label Use	26	26
Fracture	25	25
Material Erosion	25	25
Expulsion	16	16
Material Protrusion/Extrusion	14	14
Inappropriate/Inadequate Shock/Stimulation	12	12
High impedance	10	10
Patient-Device Incompatibility	10	10
Impedance Problem	9	9
Patient Device Interaction Problem	9	9
Therapeutic or Diagnostic Output Failure	7	7
Battery Problem	7	7
Break	6	6
Detachment of Device or Device Component	6	6
Lack of Effect	5	5
Manufacturing, Packaging or Shipping Problem	5	5
No Apparent Adverse Event	4	4
Unintended Electrical Shock	4	4
Device-Device Incompatibility	3	3
Temperature Problem	3	3
Microbial Contamination of Device	2	2
Physical Resistance/Sticking	2	2
Communication or Transmission Problem	2	2
Pocket Stimulation	2	2
Overheating of Device	2	2
Fluid/Blood Leak	2	2
Contamination	1	1
Material Integrity Problem	1	1
Unraveled Material	1	1
Expiration Date Error	1	1
Unintended Movement	1	1
Structural Problem	1	1
Difficult to Advance	1	1
Material Puncture/Hole	1	1
Material Deformation	1	1
Device Handling Problem	1	1
Device Alarm System	1	1
Activation Problem	1	1
Product Quality Problem	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inadequate Pain Relief	346	346
Post Operative Wound Infection	198	198
Pain	195	195
Erosion	166	166
No Clinical Signs, Symptoms or Conditions	129	129
Impaired Healing	119	119
Skin Infection	109	109
Skin Inflammation/ Irritation	99	99
Electric Shock	80	80
Unspecified Infection	62	62
Swelling/ Edema	55	55
Discomfort	51	51
Burning Sensation	47	47
Skin Erosion	31	31
Wound Dehiscence	31	31
Insufficient Information	28	28
Purulent Discharge	27	27
Erythema	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Cellulitis	17	17
Fluid Discharge	16	16
Bacterial Infection	15	15
Skin Irritation	14	14
Implant Pain	14	14
Pocket Erosion	12	12
Blister	11	11
Numbness	10	10
Hemorrhage/Bleeding	10	10
Failure of Implant	7	7
Hypersensitivity/Allergic reaction	7	7
Rash	7	7
No Code Available	6	6
Drug Resistant Bacterial Infection	6	6
Shock from Patient Lead(s)	5	5
Hematoma	5	5
Tissue Damage	5	5
Itching Sensation	5	5
Stroke/CVA	5	5
Fever	5	5
Dizziness	4	4
Inflammation	3	3
Cardiac Arrest	3	3
Abscess	3	3
Burn(s)	3	3
Myocardial Infarction	2	2
Vomiting	2	2
Swelling	2	2
Skin Tears	2	2
Chills	2	2
Scar Tissue	2	2