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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
2
CURONIX
SUBSTANTIALLY EQUIVALENT
1
MICRON MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NALU MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K232415
Nalu Neurostimulation System for Peripheral Nerve
...
NEUSPERA MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
104
104
2021
226
226
2022
183
183
2023
524
524
2024
678
678
2025
58
58
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
880
880
Migration
211
211
Use of Device Problem
157
157
Insufficient Information
98
98
Migration or Expulsion of Device
61
61
Appropriate Term/Code Not Available
44
44
Intermittent Communication Failure
37
37
Device Unsafe to Use in Environment
37
37
Malposition of Device
34
34
Fracture
29
29
Off-Label Use
28
28
Improper or Incorrect Procedure or Method
26
26
Material Erosion
25
25
Expulsion
16
16
Material Protrusion/Extrusion
14
14
Inappropriate/Inadequate Shock/Stimulation
12
12
Impedance Problem
11
11
Patient-Device Incompatibility
10
10
Lack of Effect
10
10
Patient Device Interaction Problem
8
8
Detachment of Device or Device Component
8
8
Battery Problem
7
7
Therapeutic or Diagnostic Output Failure
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
Device-Device Incompatibility
3
3
Circuit Failure
3
3
Device Appears to Trigger Rejection
3
3
Temperature Problem
3
3
Communication or Transmission Problem
2
2
Overheating of Device
2
2
Therapy Delivered to Incorrect Body Area
2
2
Microbial Contamination of Device
2
2
Physical Resistance/Sticking
2
2
Fluid/Blood Leak
2
2
Pocket Stimulation
2
2
Device Difficult to Setup or Prepare
2
2
Material Separation
1
1
Defibrillation/Stimulation Problem
1
1
Material Deformation
1
1
Structural Problem
1
1
Expiration Date Error
1
1
Device Alarm System
1
1
Incomplete or Inadequate Connection
1
1
Material Puncture/Hole
1
1
Sparking
1
1
Electrical /Electronic Property Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Inadequate Pain Relief
375
375
Pain
219
219
Post Operative Wound Infection
211
211
Erosion
168
168
No Clinical Signs, Symptoms or Conditions
146
146
Impaired Healing
130
130
Skin Infection
121
121
Skin Inflammation/ Irritation
102
102
Electric Shock
80
80
Swelling/ Edema
63
63
Discomfort
54
54
Unspecified Infection
53
53
Burning Sensation
49
49
Wound Dehiscence
39
39
Skin Erosion
32
32
Insufficient Information
30
30
Purulent Discharge
27
27
Erythema
22
22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
20
20
Fluid Discharge
17
17
Cellulitis
16
16
Implant Pain
15
15
Skin Irritation
14
14
Hemorrhage/Bleeding
14
14
Blister
13
13
Bacterial Infection
12
12
Pocket Erosion
12
12
Numbness
11
11
Failure of Implant
8
8
Rash
7
7
Hypersensitivity/Allergic reaction
7
7
Shock from Patient Lead(s)
6
6
Drug Resistant Bacterial Infection
6
6
Stroke/CVA
5
5
Fever
5
5
Itching Sensation
5
5
Abscess
4
4
Bruise/Contusion
4
4
Hematoma
4
4
Dizziness
4
4
Burn(s)
3
3
Cardiac Arrest
3
3
Urinary Tract Infection
3
3
Myocardial Infarction
2
2
Loss of consciousness
2
2
Chills
2
2
Inflammation
2
2
Vomiting
2
2
Cramp(s) /Muscle Spasm(s)
2
2
Post Traumatic Wound Infection
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Nalu Medical, Inc.
II
Jul-03-2024
2
Stimwave Technologies Inc
II
Sep-02-2020
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