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

Premarket Reviews
Manufacturer	Decision
BIONESS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOVENTUS, LLC
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC NEUROMODULATION
	SUBSTANTIALLY EQUIVALENT	1
CURONIX
	SUBSTANTIALLY EQUIVALENT	1
NEUSPERA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1073	1073
Use of Device Problem	316	316
Migration	281	281
Insufficient Information	123	123
Intermittent Communication Failure	111	111
Device Unsafe to Use in Environment	48	48
Migration or Expulsion of Device	47	47
Appropriate Term/Code Not Available	46	46
Fracture	43	43
Impedance Problem	40	40
Off-Label Use	36	36
Malposition of Device	36	36
Improper or Incorrect Procedure or Method	34	34
Expulsion	31	31
Lack of Effect	26	26
Material Erosion	24	24
Detachment of Device or Device Component	14	14
Inappropriate/Inadequate Shock/Stimulation	13	14
Material Protrusion/Extrusion	12	12
Patient-Device Incompatibility	11	11
High impedance	9	9
Therapeutic or Diagnostic Output Failure	8	11
Circuit Failure	8	8
Defective Component	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Battery Problem	6	9
Device Appears to Trigger Rejection	5	5
Unintended Electrical Shock	4	4
No Apparent Adverse Event	4	4
Patient Device Interaction Problem	4	4
Break	4	4
Device-Device Incompatibility	4	4
Overheating of Device	3	3
Defective Device	3	3
Therapy Delivered to Incorrect Body Area	3	3
Communication or Transmission Problem	3	3
Temperature Problem	3	3
Nonstandard Device	2	2
Fluid/Blood Leak	2	3
Power 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
Structural Problem	1	1
Electromagnetic Compatibility Problem	1	1
Material Deformation	1	1
Unraveled Material	1	1
Failure to Deliver	1	1
Difficult to Remove	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inadequate Pain Relief	586	589
Post Operative Wound Infection	278	278
Pain	270	273
No Clinical Signs, Symptoms or Conditions	192	193
Impaired Healing	181	181
Erosion	180	180
Skin Infection	173	173
Skin Inflammation/ Irritation	100	100
Swelling/ Edema	96	96
Electric Shock	87	87
Burning Sensation	73	73
Discomfort	65	65
Wound Dehiscence	58	58
Skin Erosion	43	43
Fluid Discharge	35	35
Insufficient Information	33	34
Purulent Discharge	32	32
Shock from Patient Lead(s)	31	32
Erythema	27	27
Unspecified Infection	27	27
Implant Pain	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	23	23
Cellulitis	22	22
Blister	22	22
Hemorrhage/Bleeding	19	19
Hypersensitivity/Allergic reaction	15	15
Bacterial Infection	15	15
Rash	14	14
Numbness	12	12
Failure of Implant	10	10
Abscess	9	9
Drug Resistant Bacterial Infection	9	9
Pocket Erosion	8	8
Itching Sensation	7	7
Stroke/CVA	7	7
Cramp(s) /Muscle Spasm(s)	6	6
Hematoma	5	5
Dizziness	5	5
Fever	5	5
Muscle Weakness	4	4
Headache	4	4
Cardiac Arrest	4	4
Nausea	4	4
Burn(s)	4	4
Bruise/Contusion	3	3
Urinary Tract Infection	3	3
Loss of consciousness	2	2
Skin Tears	2	2
Myocardial Infarction	2	2
Cancer	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Nalu Medical, Inc.	II	Jul-03-2024