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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 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1953 1953
Device Operates Differently Than Expected 231 231
High impedance 132 132
Migration 112 112
Impedance Problem 108 108
Insufficient Information 79 79
Migration or Expulsion of Device 79 79
Fracture 53 53
Use of Device Problem 50 50
Appropriate Term/Code Not Available 33 33
Improper or Incorrect Procedure or Method 25 25
Material Erosion 25 25
Inappropriate/Inadequate Shock/Stimulation 17 17
Material Protrusion/Extrusion 15 15
Malposition of Device 14 14
Low impedance 14 14
Break 14 14
Off-Label Use 13 13
Therapy Delivered to Incorrect Body Area 13 13
Device Unsafe to Use in Environment 11 11
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
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
Expulsion 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
No Apparent Adverse Event 2 2
Difficult to Advance 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Physical Resistance/Sticking 2 2
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
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
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 1096 1096
Post Operative Wound Infection 357 357
Erosion 266 266
Pain 266 266
Discomfort 214 214
Unspecified Infection 99 99
Impaired Healing 96 96
No Clinical Signs, Symptoms or Conditions 92 92
Skin Infection 89 89
Skin Inflammation/ Irritation 89 89
Therapeutic Effects, Unexpected 79 79
Electric Shock 64 64
No Known Impact Or Consequence To Patient 54 54
Skin Erosion 51 51
Burning Sensation 50 50
Erythema 48 48
Device Overstimulation of Tissue 44 44
Wound Dehiscence 41 41
Swelling/ Edema 40 40
Fall 34 34
Purulent Discharge 34 34
Swelling 34 34
Fluid Discharge 24 24
Insufficient Information 24 24
Scar Tissue 22 22
Bacterial Infection 17 17
Skin Irritation 16 16
Cellulitis 15 15
Fever 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Pocket Erosion 12 12
No Code Available 11 11
Implant Pain 11 11
Weight Changes 10 10
Numbness 9 9
Blister 8 8
Inflammation 8 8
Hypersensitivity/Allergic reaction 8 8
Staphylococcus Aureus 7 7
Shock from Patient Lead(s) 7 7
Hemorrhage/Bleeding 6 6
Headache 6 6
Hematoma 5 5
Itching Sensation 5 5
Stroke/CVA 5 5
Tissue Damage 5 5
No Consequences Or Impact To Patient 5 5
Rash 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
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
Drug Resistant Bacterial Infection 3 3
Not Applicable 2 2
Respiratory Arrest 2 2
Skin Tears 2 2
Neck Pain 2 2
Chills 2 2
Dizziness 2 2
Vomiting 2 2
Muscle Weakness 2 2
Death 2 2
Granuloma 2 2
Irritation 2 2
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
Abrasion 1 1
Abscess 1 1
Adhesion(s) 1 1
Atrial Fibrillation 1 1
Burn(s) 1 1
Pulmonary Embolism 1 1
Myocardial Infarction 1 1
Neurological Deficit/Dysfunction 1 1
Pneumonia 1 1
Increased Sensitivity 1 1
Sepsis 1 1
Septic Shock 1 1
Weakness 1 1
Twitching 1 1

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