TPLC - Total Product Life Cycle

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Device	stimulator, peripheral nerve, implanted (pain relief)
Regulation Description	Implanted peripheral nerve stimulator for 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	894	894
Migration	218	218
Use of Device Problem	163	163
Insufficient Information	100	100
Migration or Expulsion of Device	61	61
Appropriate Term/Code Not Available	44	44
Intermittent Communication Failure	42	42
Device Unsafe to Use in Environment	37	37
Malposition of Device	35	35
Fracture	29	29
Off-Label Use	28	28
Improper or Incorrect Procedure or Method	27	27
Material Erosion	25	25
Expulsion	16	16
Material Protrusion/Extrusion	14	14
Impedance Problem	12	12
Inappropriate/Inadequate Shock/Stimulation	12	12
Lack of Effect	12	12
Patient-Device Incompatibility	10	10
Patient Device Interaction Problem	8	8
Detachment of Device or Device Component	8	8
Therapeutic or Diagnostic Output Failure	7	7
Battery Problem	7	7
High impedance	6	6
Break	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Unintended Electrical Shock	4	4
No Apparent Adverse Event	4	4
Circuit Failure	3	3
Device-Device Incompatibility	3	3
Temperature Problem	3	3
Device Appears to Trigger Rejection	3	3
Therapy Delivered to Incorrect Body Area	2	2
Fluid/Blood Leak	2	2
Overheating of Device	2	2
Pocket Stimulation	2	2
Device Difficult to Setup or Prepare	2	2
Microbial Contamination of Device	2	2
Physical Resistance/Sticking	2	2
Communication or Transmission Problem	2	2
Structural Problem	1	1
Material Deformation	1	1
Device Handling Problem	1	1
Unraveled Material	1	1
Contamination	1	1
Material Integrity Problem	1	1
Expiration Date Error	1	1
Product Quality Problem	1	1
Material Separation	1	1
Defibrillation/Stimulation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inadequate Pain Relief	387	387
Pain	223	223
Post Operative Wound Infection	212	212
Erosion	170	170
No Clinical Signs, Symptoms or Conditions	147	147
Impaired Healing	134	134
Skin Infection	126	126
Skin Inflammation/ Irritation	103	103
Electric Shock	81	81
Swelling/ Edema	65	65
Discomfort	54	54
Unspecified Infection	53	53
Burning Sensation	51	51
Wound Dehiscence	43	43
Skin Erosion	33	33
Insufficient Information	31	31
Purulent Discharge	27	27
Erythema	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Fluid Discharge	18	18
Cellulitis	16	16
Hemorrhage/Bleeding	15	15
Implant Pain	15	15
Skin Irritation	14	14
Blister	14	14
Pocket Erosion	13	13
Bacterial Infection	12	12
Numbness	11	11
Failure of Implant	9	9
Hypersensitivity/Allergic reaction	7	7
Rash	7	7
Shock from Patient Lead(s)	6	6
Drug Resistant Bacterial Infection	6	6
Stroke/CVA	6	6
Hematoma	5	5
Itching Sensation	5	5
Fever	5	5
Dizziness	4	4
Abscess	4	4
Cardiac Arrest	4	4
Bruise/Contusion	4	4
Cramp(s) /Muscle Spasm(s)	3	3
Burn(s)	3	3
Urinary Tract Infection	3	3
Loss of consciousness	2	2
Skin Tears	2	2
Tissue Damage	2	2
Myocardial Infarction	2	2
Granuloma	2	2
Scar Tissue	2	2