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	1012	1012
Use of Device Problem	279	279
Migration	252	252
Insufficient Information	116	116
Intermittent Communication Failure	99	99
Device Unsafe to Use in Environment	48	48
Migration or Expulsion of Device	47	47
Appropriate Term/Code Not Available	46	46
Fracture	41	41
Malposition of Device	35	35
Off-Label Use	34	34
Impedance Problem	33	33
Improper or Incorrect Procedure or Method	28	28
Lack of Effect	25	25
Material Erosion	24	24
Expulsion	23	23
Detachment of Device or Device Component	13	13
Material Protrusion/Extrusion	12	12
Inappropriate/Inadequate Shock/Stimulation	12	13
Patient-Device Incompatibility	10	10
Therapeutic or Diagnostic Output Failure	8	11
High impedance	8	8
Circuit Failure	8	8
Battery Problem	6	9
Manufacturing, Packaging or Shipping Problem	5	5
Device Appears to Trigger Rejection	5	5
Defective Component	4	4
Patient Device Interaction Problem	4	4
Unintended Electrical Shock	4	4
Break	4	4
No Apparent Adverse Event	4	4
Device-Device Incompatibility	4	4
Defective Device	3	3
Overheating of Device	3	3
Therapy Delivered to Incorrect Body Area	3	3
Temperature Problem	3	3
Communication or Transmission Problem	3	3
Fluid/Blood Leak	2	3
Microbial Contamination of Device	2	2
Device Difficult to Setup or Prepare	2	2
Physical Resistance/Sticking	2	2
Device Handling Problem	2	2
Power Problem	2	2
Electrical /Electronic Property Problem	1	1
Human-Device Interface Problem	1	1
Inadequate or Insufficient Training	1	1
Pocket Stimulation	1	1
Nonstandard Device	1	1
Excessive Heating	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inadequate Pain Relief	540	543
Pain	255	258
Post Operative Wound Infection	253	253
No Clinical Signs, Symptoms or Conditions	182	183
Erosion	167	167
Impaired Healing	164	164
Skin Infection	164	164
Skin Inflammation/ Irritation	99	99
Swelling/ Edema	88	88
Electric Shock	86	86
Burning Sensation	68	68
Discomfort	61	61
Wound Dehiscence	51	51
Skin Erosion	41	41
Insufficient Information	32	33
Purulent Discharge	31	31
Fluid Discharge	30	30
Unspecified Infection	27	27
Shock from Patient Lead(s)	26	27
Erythema	23	23
Cellulitis	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Implant Pain	19	19
Blister	19	19
Hemorrhage/Bleeding	17	17
Hypersensitivity/Allergic reaction	14	14
Bacterial Infection	13	13
Numbness	12	12
Rash	11	11
Failure of Implant	10	10
Drug Resistant Bacterial Infection	9	9
Abscess	8	8
Itching Sensation	7	7
Pocket Erosion	7	7
Stroke/CVA	6	6
Cramp(s) /Muscle Spasm(s)	5	5
Fever	5	5
Dizziness	4	4
Hematoma	4	4
Muscle Weakness	4	4
Cardiac Arrest	4	4
Burn(s)	4	4
Headache	3	3
Bruise/Contusion	3	3
Urinary Tract Infection	3	3
Loss of consciousness	2	2
Cancer	2	2
Granuloma	2	2
Skin Tears	2	2
Myocardial Infarction	2	2

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