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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
MICRON MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NALU MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
NALU MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
NEUSPERA MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
64
64
2020
104
104
2021
226
226
2022
183
183
2023
524
524
2024
263
263
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
772
772
Migration
132
132
Insufficient Information
78
78
Use of Device Problem
77
77
Migration or Expulsion of Device
58
58
Appropriate Term/Code Not Available
36
36
Malposition of Device
26
26
Improper or Incorrect Procedure or Method
25
25
Material Erosion
25
25
Fracture
19
19
Off-Label Use
16
16
Device Unsafe to Use in Environment
16
16
Material Protrusion/Extrusion
14
14
Inappropriate/Inadequate Shock/Stimulation
12
12
Patient-Device Incompatibility
10
10
Patient Device Interaction Problem
9
9
High impedance
8
8
Battery Problem
7
7
Expulsion
7
7
Therapeutic or Diagnostic Output Failure
7
7
Impedance Problem
6
6
Break
6
6
Manufacturing, Packaging or Shipping Problem
4
4
Detachment of Device or Device Component
4
4
No Apparent Adverse Event
4
4
Unintended Electrical Shock
4
4
Temperature Problem
3
3
Device-Device Incompatibility
3
3
Microbial Contamination of Device
2
2
Fluid/Blood Leak
2
2
Overheating of Device
2
2
Pocket Stimulation
2
2
Physical Resistance/Sticking
2
2
Incomplete or Inadequate Connection
1
1
Intermittent Communication Failure
1
1
Activation Problem
1
1
Lack of Effect
1
1
Device Alarm System
1
1
Unintended Movement
1
1
Device Handling Problem
1
1
Inadequate or Insufficient Training
1
1
Unraveled Material
1
1
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Material Separation
1
1
Defibrillation/Stimulation Problem
1
1
Failure to Conduct
1
1
Contamination
1
1
Electrical /Electronic Property Problem
1
1
Failure to Deliver Energy
1
1
Structural Problem
1
1
Expiration Date Error
1
1
Sparking
1
1
Difficult to Advance
1
1
Device Dislodged or Dislocated
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Inadequate Pain Relief
242
242
Post Operative Wound Infection
166
166
Pain
165
165
Erosion
151
151
No Clinical Signs, Symptoms or Conditions
99
99
Impaired Healing
97
97
Skin Infection
96
96
Skin Inflammation/ Irritation
92
92
Electric Shock
64
64
Unspecified Infection
56
56
Swelling/ Edema
47
47
Discomfort
42
42
Burning Sensation
40
40
Skin Erosion
30
30
Purulent Discharge
26
26
Insufficient Information
26
26
Erythema
22
22
Wound Dehiscence
20
20
Cellulitis
17
17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
16
Skin Irritation
14
14
Bacterial Infection
13
13
Pocket Erosion
12
12
Implant Pain
11
11
Blister
10
10
Fluid Discharge
10
10
Numbness
9
9
Hemorrhage/Bleeding
8
8
Hypersensitivity/Allergic reaction
7
7
Rash
7
7
Failure of Implant
7
7
No Code Available
6
6
Shock from Patient Lead(s)
5
5
Tissue Damage
5
5
Itching Sensation
5
5
Stroke/CVA
5
5
Fever
5
5
Hematoma
4
4
Dizziness
4
4
Drug Resistant Bacterial Infection
4
4
Inflammation
3
3
Cardiac Arrest
3
3
Bruise/Contusion
2
2
Death
2
2
Granuloma
2
2
Skin Tears
2
2
Post Traumatic Wound Infection
2
2
Urinary Tract Infection
2
2
Skin Discoloration
2
2
Vomiting
2
2
Chills
2
2
Swelling
2
2
Not Applicable
2
2
Respiratory Arrest
2
2
Partial Hearing Loss
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Osteomyelitis
1
1
Convulsion/Seizure
1
1
Paresthesia
1
1
Unspecified Tissue Injury
1
1
Peripheral Edema
1
1
Nodule
1
1
Therapeutic Effects, Unexpected
1
1
Tinnitus
1
1
Scar Tissue
1
1
Septic Shock
1
1
Seroma
1
1
Twitching
1
1
Headache, Lumbar Puncture
1
1
Perforation of Vessels
1
1
Low Oxygen Saturation
1
1
Decreased Respiratory Rate
1
1
Low Cardiac Output
1
1
Confusion/ Disorientation
1
1
No Known Impact Or Consequence To Patient
1
1
Sneezing
1
1
Hip Fracture
1
1
Coma
1
1
Loss of consciousness
1
1
Fungal Infection
1
1
Respiratory Tract Infection
1
1
Headache
1
1
High Blood Pressure/ Hypertension
1
1
Low Blood Pressure/ Hypotension
1
1
Hyperemia
1
1
Irritation
1
1
Pneumonia
1
1
Damage to Ligament(s)
1
1
Muscle Weakness
1
1
Myocardial Infarction
1
1
Nausea
1
1
Device Overstimulation of Tissue
1
1
Burn(s)
1
1
Pulmonary Embolism
1
1
Abrasion
1
1
Abscess
1
1
Adhesion(s)
1
1
Aneurysm
1
1
Atrial Fibrillation
1
1
Gastritis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stimwave Technologies Inc
II
Sep-02-2020
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