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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, peripheral nerve, implanted (pain relief)
Product CodeGZF
Regulation Number 882.5870
Device Class 2


Premarket Reviews
ManufacturerDecision
BIONESS INC.
  SUBSTANTIALLY EQUIVALENT 3
BIONESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRON MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NALU MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
NALU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 187 187

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1972 1972
Device Operates Differently Than Expected 231 231
High impedance 132 132
Migration 118 118
Impedance Problem 110 110
Migration or Expulsion of Device 88 88
Insufficient Information 80 80
Use of Device Problem 64 64
Fracture 56 56
Appropriate Term/Code Not Available 36 36
Material Erosion 25 25
Improper or Incorrect Procedure or Method 25 25
Malposition of Device 22 22
Inappropriate/Inadequate Shock/Stimulation 17 17
Off-Label Use 15 15
Material Protrusion/Extrusion 15 15
Low impedance 14 14
Break 14 14
Therapy Delivered to Incorrect Body Area 13 13
Device Unsafe to Use in Environment 12 12
Patient-Device Incompatibility 10 10
Patient Device Interaction Problem 10 10
Temperature Problem 7 7
Therapeutic or Diagnostic Output Failure 7 7
Pocket Stimulation 6 6
Expulsion 6 6
Disconnection 6 6
Self-Activation or Keying 4 4
No Device Output 4 4
Unintended Movement 4 4
Unintended Electrical Shock 4 4
Battery Problem 4 4
Communication or Transmission Problem 3 3
Cut In Material 3 3
Device-Device Incompatibility 3 3
Failure to Deliver Energy 3 3
Fluid/Blood Leak 2 2
Kinked 2 2
Overheating of Device 2 2
Microbial Contamination of Device 2 2
Difficult to Advance 2 2
Manufacturing, Packaging or Shipping Problem 2 2
No Apparent Adverse Event 2 2
Physical Resistance/Sticking 2 2
Unauthorized Access to Computer System 1 1
Incomplete or Inadequate Connection 1 1
Activation Problem 1 1
Lack of Effect 1 1
Device Handling Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Device Dislodged or Dislocated 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Low Battery 1 1
Sparking 1 1
Detachment of Device or Device Component 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 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 Interrogate 1 1
Device Expiration Issue 1 1
Electrical /Electronic Property Problem 1 1
Device Alarm System 1 1
Premature Discharge of Battery 1 1
Failure to Charge 1 1
Failure to Conduct 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 1113 1113
Post Operative Wound Infection 360 360
Pain 273 273
Erosion 271 271
Discomfort 219 219
Impaired Healing 100 100
Unspecified Infection 99 99
No Clinical Signs, Symptoms or Conditions 94 94
Skin Infection 93 93
Skin Inflammation/ Irritation 91 91
Therapeutic Effects, Unexpected 79 79
Electric Shock 65 65
No Known Impact Or Consequence To Patient 54 54
Skin Erosion 51 51
Burning Sensation 51 51
Erythema 48 48
Wound Dehiscence 46 46
Device Overstimulation of Tissue 44 44
Swelling/ Edema 42 42
Swelling 34 34
Fall 34 34
Purulent Discharge 34 34
Insufficient Information 25 25
Fluid Discharge 24 24
Scar Tissue 22 22
Bacterial Infection 18 18
Cellulitis 16 16
Skin Irritation 16 16
Fever 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Pocket Erosion 12 12
Implant Pain 11 11
No Code Available 11 11
Blister 10 10
Weight Changes 10 10
Numbness 9 9
Hypersensitivity/Allergic reaction 9 9
Inflammation 8 8
Hemorrhage/Bleeding 7 7
Staphylococcus Aureus 7 7
Shock from Patient Lead(s) 7 7
Rash 6 6
Itching Sensation 6 6
Headache 6 6
Hematoma 5 5
Stroke/CVA 5 5
Tissue Damage 5 5
No Consequences Or Impact To Patient 5 5
Foreign Body In Patient 5 5
Therapeutic Response, Decreased 5 5
Tissue Breakdown 4 4
Post Traumatic Wound Infection 4 4
No Information 4 4
Drug Resistant Bacterial Infection 4 4
Seizures 4 4
Failure of Implant 4 4
Cardiopulmonary Arrest 4 4
Muscle Stimulation 4 4
Edema 4 4
High Blood Pressure/ Hypertension 3 3
Low Blood Pressure/ Hypotension 3 3
Bruise/Contusion 3 3
Abdominal Pain 3 3
Cardiac Arrest 3 3
Cerebrospinal Fluid Leakage 3 3
Nausea 3 3
Seroma 3 3
Skin Discoloration 3 3
Discharge 3 3
Dizziness 3 3
Chills 2 2
Vomiting 2 2
Muscle Weakness 2 2
Death 2 2
Granuloma 2 2
Irritation 2 2
Respiratory Arrest 2 2
Neck Pain 2 2
Not Applicable 2 2
Skin Tears 2 2
Confusion/ Disorientation 1 1
Low Oxygen Saturation 1 1
Decreased Respiratory Rate 1 1
Low Cardiac Output 1 1
Hip Fracture 1 1
Coma 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Respiratory Tract Infection 1 1
Convulsion/Seizure 1 1
Paresthesia 1 1
Partial Hearing Loss 1 1
Nodule 1 1
Peripheral Edema 1 1
Damage to Ligament(s) 1 1
Fatigue 1 1
Bone Fracture(s) 1 1
Gastritis 1 1
Chest Pain 1 1
Cyst(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stimwave Technologies Inc II Sep-02-2020
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