Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 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
-
-