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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)
Regulation Description Implanted peripheral nerve stimulator for pain relief.
Product CodeGZF
Regulation Number 882.5870
Device Class 2


Premarket Reviews
ManufacturerDecision
BIONESS INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K200482  StimRouter Neuromodulation System
  2.  K211965  StimRouter Neuromodulation System
CURONIX
  SUBSTANTIALLY EQUIVALENT 1
MICRON MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NALU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUSPERA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 104 104
2021 226 226
2022 183 183
2023 524 524
2024 678 678
2025 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 880 880
Migration 211 211
Use of Device Problem 157 157
Insufficient Information 98 98
Migration or Expulsion of Device 61 61
Appropriate Term/Code Not Available 44 44
Intermittent Communication Failure 37 37
Device Unsafe to Use in Environment 37 37
Malposition of Device 34 34
Fracture 29 29
Off-Label Use 28 28
Improper or Incorrect Procedure or Method 26 26
Material Erosion 25 25
Expulsion 16 16
Material Protrusion/Extrusion 14 14
Inappropriate/Inadequate Shock/Stimulation 12 12
Impedance Problem 11 11
Patient-Device Incompatibility 10 10
Lack of Effect 10 10
Patient Device Interaction Problem 8 8
Detachment of Device or Device Component 8 8
Battery Problem 7 7
Therapeutic or Diagnostic Output Failure 7 7
High impedance 6 6
Break 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Unintended Electrical Shock 4 4
No Apparent Adverse Event 4 4
Device-Device Incompatibility 3 3
Circuit Failure 3 3
Device Appears to Trigger Rejection 3 3
Temperature Problem 3 3
Communication or Transmission Problem 2 2
Overheating of Device 2 2
Therapy Delivered to Incorrect Body Area 2 2
Microbial Contamination of Device 2 2
Physical Resistance/Sticking 2 2
Fluid/Blood Leak 2 2
Pocket Stimulation 2 2
Device Difficult to Setup or Prepare 2 2
Material Separation 1 1
Defibrillation/Stimulation Problem 1 1
Material Deformation 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Device Alarm System 1 1
Incomplete or Inadequate Connection 1 1
Material Puncture/Hole 1 1
Sparking 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 375 375
Pain 219 219
Post Operative Wound Infection 211 211
Erosion 168 168
No Clinical Signs, Symptoms or Conditions 146 146
Impaired Healing 130 130
Skin Infection 121 121
Skin Inflammation/ Irritation 102 102
Electric Shock 80 80
Swelling/ Edema 63 63
Discomfort 54 54
Unspecified Infection 53 53
Burning Sensation 49 49
Wound Dehiscence 39 39
Skin Erosion 32 32
Insufficient Information 30 30
Purulent Discharge 27 27
Erythema 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Fluid Discharge 17 17
Cellulitis 16 16
Implant Pain 15 15
Skin Irritation 14 14
Hemorrhage/Bleeding 14 14
Blister 13 13
Bacterial Infection 12 12
Pocket Erosion 12 12
Numbness 11 11
Failure of Implant 8 8
Rash 7 7
Hypersensitivity/Allergic reaction 7 7
Shock from Patient Lead(s) 6 6
Drug Resistant Bacterial Infection 6 6
Itching Sensation 5 5
Stroke/CVA 5 5
Fever 5 5
Dizziness 4 4
Hematoma 4 4
Abscess 4 4
Bruise/Contusion 4 4
Urinary Tract Infection 3 3
Burn(s) 3 3
Cardiac Arrest 3 3
Chills 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Inflammation 2 2
Vomiting 2 2
Tissue Damage 2 2
Swelling 2 2
Paresthesia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Nalu Medical, Inc. II Jul-03-2024
2 Stimwave Technologies Inc II Sep-02-2020
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