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	1041	1041
Migration	267	267
Use of Device Problem	256	256
Insufficient Information	115	115
Intermittent Communication Failure	94	94
Migration or Expulsion of Device	63	64
Device Unsafe to Use in Environment	48	48
Appropriate Term/Code Not Available	46	46
Fracture	42	42
Malposition of Device	35	35
Off-Label Use	34	34
Improper or Incorrect Procedure or Method	28	28
Impedance Problem	26	26
Lack of Effect	25	25
Material Erosion	25	25
Expulsion	21	21
Material Protrusion/Extrusion	14	15
Inappropriate/Inadequate Shock/Stimulation	12	13
Detachment of Device or Device Component	12	12
Patient-Device Incompatibility	10	10
High impedance	8	8
Patient Device Interaction Problem	8	8
Therapeutic or Diagnostic Output Failure	8	11
Battery Problem	7	11
Circuit Failure	7	7
Manufacturing, Packaging or Shipping Problem	5	5
Device Appears to Trigger Rejection	5	5
Break	5	5
No Apparent Adverse Event	4	4
Unintended Electrical Shock	4	4
Device-Device Incompatibility	4	4
Defective Component	3	3
Overheating of Device	3	3
Therapy Delivered to Incorrect Body Area	3	3
Communication or Transmission Problem	3	3
Temperature Problem	3	3
Power Problem	2	2
Pocket Stimulation	2	2
Fluid/Blood Leak	2	2
Product Quality Problem	2	2
Device Handling Problem	2	2
Device Difficult to Setup or Prepare	2	2
Microbial Contamination of Device	2	2
Physical Resistance/Sticking	2	2
Material Deformation	1	1
Structural Problem	1	1
Unraveled Material	1	1
Failure to Deliver	1	1
Contamination	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inadequate Pain Relief	523	526
Pain	257	261
Post Operative Wound Infection	249	249
Erosion	192	192
No Clinical Signs, Symptoms or Conditions	181	181
Impaired Healing	164	164
Skin Infection	162	162
Skin Inflammation/ Irritation	109	109
Electric Shock	88	88
Swelling/ Edema	86	86
Burning Sensation	66	66
Discomfort	63	63
Unspecified Infection	60	60
Wound Dehiscence	53	53
Skin Erosion	41	41
Insufficient Information	32	32
Purulent Discharge	32	32
Fluid Discharge	27	27
Shock from Patient Lead(s)	25	26
Erythema	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Cellulitis	21	21
Implant Pain	19	19
Hemorrhage/Bleeding	17	17
Blister	17	17
Skin Irritation	14	14
Pocket Erosion	14	14
Numbness	13	13
Hypersensitivity/Allergic reaction	12	12
Bacterial Infection	12	12
Rash	11	11
Failure of Implant	10	10
Drug Resistant Bacterial Infection	8	8
Itching Sensation	7	7
Abscess	6	6
Stroke/CVA	6	6
Hematoma	5	5
Fever	5	5
Cramp(s) /Muscle Spasm(s)	4	4
Cardiac Arrest	4	4
Muscle Weakness	4	4
Dizziness	4	4
Burn(s)	4	4
Bruise/Contusion	4	4
Nausea	3	3
Urinary Tract Infection	3	3
Granuloma	2	2
Skin Tears	2	2
Tissue Damage	2	2
Myocardial Infarction	2	2