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TPLC
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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
MDR Year
MDR Reports
MDR Events
2014
268
268
2015
346
346
2016
413
413
2017
330
330
2018
318
318
2019
64
64
2020
104
104
2021
226
226
2022
183
183
2023
524
524
2024
433
433
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
Break
14
14
Low impedance
14
14
Expulsion
13
13
Therapy Delivered to Incorrect Body Area
13
13
Patient-Device Incompatibility
10
10
Patient Device Interaction Problem
10
10
Intermittent Communication Failure
10
10
Temperature Problem
7
7
Therapeutic or Diagnostic Output Failure
7
7
Battery Problem
7
7
Disconnection
6
6
Pocket Stimulation
6
6
Communication or Transmission Problem
5
5
No Device Output
4
4
Detachment of Device or Device Component
4
4
No Apparent Adverse Event
4
4
Self-Activation or Keying
4
4
Unintended Electrical Shock
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Unintended Movement
4
4
Device-Device Incompatibility
3
3
Failure to Deliver Energy
3
3
Cut In Material
3
3
Overheating of Device
2
2
Fluid/Blood Leak
2
2
Microbial Contamination of Device
2
2
Lack of Effect
2
2
Kinked
2
2
Physical Resistance/Sticking
2
2
Difficult to Advance
2
2
Biocompatibility
1
1
Sparking
1
1
Nonstandard Device
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
No Known Impact Or Consequence To Patient
54
54
Wound Dehiscence
54
54
Skin Erosion
52
52
Swelling/ Edema
52
52
Erythema
48
48
Device Overstimulation of Tissue
44
44
Purulent Discharge
37
37
Swelling
34
34
Fall
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
Failure of Implant
7
7
Shock from Patient Lead(s)
7
7
Rash
7
7
Staphylococcus Aureus
7
7
Headache
6
6
Hematoma
6
6
Drug Resistant Bacterial Infection
6
6
Itching Sensation
6
6
Therapeutic Response, Decreased
5
5
Tissue Damage
5
5
Stroke/CVA
5
5
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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