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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
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 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 726 726
Migration 112 112
Insufficient Information 76 76
Migration or Expulsion of Device 49 49
Use of Device Problem 49 49
Appropriate Term/Code Not Available 33 33
Improper or Incorrect Procedure or Method 25 25
Material Erosion 25 25
Fracture 15 15
Material Protrusion/Extrusion 14 14
Off-Label Use 13 13
Inappropriate/Inadequate Shock/Stimulation 12 12
Malposition of Device 11 11
Device Unsafe to Use in Environment 11 11
Patient-Device Incompatibility 10 10
Patient Device Interaction Problem 9 9
High impedance 8 8
Therapeutic or Diagnostic Output Failure 7 7
Break 6 6
Battery Problem 4 4
Impedance Problem 4 4
Unintended Electrical Shock 4 4
Temperature Problem 3 3
Expulsion 3 3
Device-Device Incompatibility 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Microbial Contamination of Device 2 2
Fluid/Blood Leak 2 2
Overheating of Device 2 2
Pocket Stimulation 2 2
No Apparent Adverse Event 2 2
Physical Resistance/Sticking 2 2
Device Handling Problem 1 1
Incomplete or Inadequate Connection 1 1
Activation Problem 1 1
Lack of Effect 1 1
Unintended Movement 1 1
Device Alarm System 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
Detachment of Device or Device Component 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Difficult to Advance 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 206 206
Post Operative Wound Infection 154 154
Pain 152 152
Erosion 143 143
No Clinical Signs, Symptoms or Conditions 91 91
Skin Infection 89 89
Skin Inflammation/ Irritation 89 89
Impaired Healing 85 85
Electric Shock 63 63
Unspecified Infection 55 55
Swelling/ Edema 40 40
Burning Sensation 33 33
Discomfort 32 32
Skin Erosion 29 29
Purulent Discharge 24 24
Insufficient Information 24 24
Erythema 22 22
Cellulitis 15 15
Wound Dehiscence 14 14
Skin Irritation 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Pocket Erosion 12 12
Bacterial Infection 12 12
Implant Pain 11 11
Fluid Discharge 9 9
Numbness 9 9
Blister 8 8
No Code Available 6 6
Hemorrhage/Bleeding 6 6
Hypersensitivity/Allergic reaction 6 6
Stroke/CVA 5 5
Shock from Patient Lead(s) 5 5
Rash 5 5
Tissue Damage 5 5
Failure of Implant 4 4
Fever 4 4
Hematoma 4 4
Itching Sensation 4 4
Inflammation 3 3
Cardiac Arrest 3 3
Drug Resistant Bacterial Infection 3 3
Respiratory Arrest 2 2
Bruise/Contusion 2 2
Death 2 2
Granuloma 2 2
Skin Discoloration 2 2
Chills 2 2
Dizziness 2 2
Swelling 2 2
Not Applicable 2 2
Vomiting 2 2
Post Traumatic Wound Infection 2 2
Low Oxygen Saturation 1 1
Decreased Respiratory Rate 1 1
Low Cardiac Output 1 1
Skin Tears 1 1
Confusion/ Disorientation 1 1
Coma 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Respiratory Tract Infection 1 1
No Known Impact Or Consequence To Patient 1 1
Convulsion/Seizure 1 1
Paresthesia 1 1
Therapeutic Effects, Unexpected 1 1
Tinnitus 1 1
Scar Tissue 1 1
Septic Shock 1 1
Seroma 1 1
Sneezing 1 1
Twitching 1 1
Headache, Lumbar Puncture 1 1
Urinary Tract Infection 1 1
Headache 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 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
Atrial Fibrillation 1 1
Gastritis 1 1
Fall 1 1
Cerebrospinal Fluid Leakage 1 1
Chest Pain 1 1
Cyst(s) 1 1
Partial Hearing Loss 1 1
Nodule 1 1
Peripheral Edema 1 1

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