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

Premarket Reviews
Manufacturer	Decision
BIONESS INC.
	SUBSTANTIALLY EQUIVALENT	3
BIONESS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CURONIX
	SUBSTANTIALLY EQUIVALENT	1
MICRON MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NALU MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
NALU MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
NEUSPERA MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
STIMQ LLC
	SUBSTANTIALLY EQUIVALENT	1
STIMWAVE TECHNOLOGIES INC.,DBA STIMQ LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2046	2046
Device Operates Differently Than Expected	231	231
Migration	171	171
High impedance	133	133
Impedance Problem	111	111
Use of Device Problem	110	110
Migration or Expulsion of Device	90	90
Insufficient Information	89	89
Fracture	62	62
Appropriate Term/Code Not Available	38	38
Malposition of Device	36	36
Improper or Incorrect Procedure or Method	26	26
Material Erosion	25	25
Device Unsafe to Use in Environment	24	24
Off-Label Use	20	20
Inappropriate/Inadequate Shock/Stimulation	17	17
Material Protrusion/Extrusion	15	15
Low impedance	14	14
Break	14	14
Therapy Delivered to Incorrect Body Area	13	13
Expulsion	13	13
Patient-Device Incompatibility	10	10
Patient Device Interaction Problem	10	10
Intermittent Communication Failure	10	10
Therapeutic or Diagnostic Output Failure	7	7
Battery Problem	7	7
Temperature Problem	7	7
Pocket Stimulation	6	6
Disconnection	6	6
Communication or Transmission Problem	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Detachment of Device or Device Component	4	4
Unintended Movement	4	4
No Apparent Adverse Event	4	4
Unintended Electrical Shock	4	4
No Device Output	4	4
Self-Activation or Keying	4	4
Device-Device Incompatibility	3	3
Failure to Deliver Energy	3	3
Cut In Material	3	3
Kinked	2	2
Difficult to Advance	2	2
Physical Resistance/Sticking	2	2
Fluid/Blood Leak	2	2
Microbial Contamination of Device	2	2
Lack of Effect	2	2
Overheating of Device	2	2
Activation Problem	1	1
Incomplete or Inadequate Connection	1	1
Unraveled Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inadequate Pain Relief	1193	1193
Post Operative Wound Infection	387	387
Pain	297	297
Erosion	283	283
Discomfort	229	229
Impaired Healing	120	120
No Clinical Signs, Symptoms or Conditions	114	114
Unspecified Infection	105	105
Skin Infection	101	101
Skin Inflammation/ Irritation	97	97
Therapeutic Effects, Unexpected	79	79
Electric Shock	74	74
Burning Sensation	60	60
Wound Dehiscence	54	54
No Known Impact Or Consequence To Patient	54	54
Swelling/ Edema	52	52
Skin Erosion	52	52
Erythema	48	48
Device Overstimulation of Tissue	44	44
Purulent Discharge	37	37
Fall	34	34
Swelling	34	34
Fluid Discharge	30	30
Insufficient Information	27	27
Scar Tissue	22	22
Bacterial Infection	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Cellulitis	17	17
Skin Irritation	16	16
Fever	16	16
Implant Pain	13	13
Pocket Erosion	12	12
No Code Available	11	11
Blister	11	11
Numbness	10	10
Weight Changes	10	10
Hypersensitivity/Allergic reaction	9	9
Hemorrhage/Bleeding	9	9
Inflammation	8	8
Rash	7	7
Shock from Patient Lead(s)	7	7
Failure of Implant	7	7
Staphylococcus Aureus	7	7
Headache	6	6
Itching Sensation	6	6
Hematoma	6	6
Drug Resistant Bacterial Infection	6	6
No Consequences Or Impact To Patient	5	5
Stroke/CVA	5	5
Therapeutic Response, Decreased	5	5