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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 1
STIMWAVE TECHNOLOGIES INC.,DBA STIMQ LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 330 330
2018 318 318
2019 64 64
2020 104 104
2021 226 226
2022 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 867 867
Migration or Expulsion of Device 47 47
Migration 40 40
High impedance 35 35
Impedance Problem 30 30
Insufficient Information 26 26
Material Erosion 25 25
Appropriate Term/Code Not Available 20 20
Fracture 16 16
Material Protrusion/Extrusion 15 15
Inappropriate/Inadequate Shock/Stimulation 13 13
Patient Device Interaction Problem 9 9
Patient-Device Incompatibility 7 7
Break 7 7
Device Operates Differently Than Expected 6 6
Improper or Incorrect Procedure or Method 5 5
Therapeutic or Diagnostic Output Failure 5 5
Unintended Electrical Shock 4 4
Battery Problem 3 3
Expulsion 3 3
Temperature Problem 3 3
Off-Label Use 3 3
Failure to Deliver Energy 2 2
Overheating of Device 2 2
Pocket Stimulation 2 2
Fluid Leak 2 2
Microbial Contamination of Device 2 2
Structural Problem 1 1
Expiration Date Error 1 1
Low Battery 1 1
Sparking 1 1
Malposition of Device 1 1
Device Inoperable 1 1
Unraveled Material 1 1
Material Deformation 1 1
Device Alarm System 1 1
Premature Discharge of Battery 1 1
Failure to Conduct 1 1
Contamination 1 1
Disconnection 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Material Separation 1 1
Defibrillation/Stimulation Problem 1 1
Incomplete or Inadequate Connection 1 1
Unauthorized Access to Computer System 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 373 373
Erosion 144 144
Post Operative Wound Infection 140 140
Pain 124 124
Skin Inflammation/ Irritation 80 80
Discomfort 77 77
Unspecified Infection 75 75
Skin Infection 34 34
Impaired Healing 32 32
Erythema 30 30
Electric Shock 29 29
Swelling/ Edema 26 26
No Clinical Signs, Symptoms or Conditions 26 26
Therapeutic Effects, Unexpected 25 25
Skin Erosion 20 20
Purulent Discharge 20 20
Swelling 18 18
No Known Impact Or Consequence To Patient 16 16
Skin Irritation 14 14
Fall 14 14
Burning Sensation 13 13
Fluid Discharge 11 11
No Code Available 11 11
Pocket Erosion 10 10
Bacterial Infection 10 10
Scar Tissue 9 9
Wound Dehiscence 8 8
Device Overstimulation of Tissue 8 8
Implant Pain 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Insufficient Information 6 6
Cellulitis 6 6
Tissue Damage 5 5
Weight Changes 5 5
No Consequences Or Impact To Patient 5 5
Numbness 5 5
Therapeutic Response, Decreased 5 5
Tissue Breakdown 4 4
Post Traumatic Wound Infection 4 4
Hematoma 4 4
Hypersensitivity/Allergic reaction 4 4
Hemorrhage/Bleeding 3 3
Nausea 3 3
Fever 3 3
No Information 3 3
Shock from Patient Lead(s) 3 3
Blister 3 3
Drug Resistant Bacterial Infection 2 2
Not Applicable 2 2
Respiratory Arrest 2 2
Death 2 2
Granuloma 2 2
Headache 2 2
Bruise/Contusion 2 2
Irritation 2 2
Failure of Implant 2 2
Staphylococcus Aureus 2 2
Vomiting 2 2
Dizziness 2 2
Seroma 2 2
Skin Discoloration 1 1
Increased Sensitivity 1 1
Septic Shock 1 1
Rash 1 1
Headache, Lumbar Puncture 1 1
Chills 1 1
Urinary Tract Infection 1 1
Low Oxygen Saturation 1 1
Decreased Respiratory Rate 1 1
Low Cardiac Output 1 1
Confusion/ Disorientation 1 1
Foreign Body In Patient 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Respiratory Tract Infection 1 1
Sneezing 1 1
Inflammation 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Itching Sensation 1 1
Damage to Ligament(s) 1 1
Muscle Weakness 1 1
Pneumonia 1 1
Cardiac Arrest 1 1
Adhesion(s) 1 1
Stroke/CVA 1 1
Cerebrospinal Fluid Leakage 1 1
Cyst(s) 1 1
Gastritis 1 1
Partial Hearing Loss 1 1
Paresthesia 1 1
Peripheral Edema 1 1

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