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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, nerve, electrical, percutaneous (pens), for pain relief
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,
Product CodeNHI
Regulation Number 882.5890
Device Class 2


Premarket Reviews
ManufacturerDecision
DYANSYS, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPR THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 6 6
2022 8 8
2023 25 25
2024 12 12
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 46 46
Fracture 6 6
Off-Label Use 2 2
Difficult to Remove 2 2
Improper or Incorrect Procedure or Method 2 2
Activation, Positioning or Separation Problem 1 1
Break 1 1
Migration or Expulsion of Device 1 1
Physical Resistance/Sticking 1 1
Patient-Device Incompatibility 1 1
Unraveled Material 1 1
Use of Device Problem 1 1
Difficult or Delayed Separation 1 1
Retraction Problem 1 1
Unexpected Therapeutic Results 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 24 24
Skin Inflammation/ Irritation 17 17
Pain 16 16
Fluid Discharge 13 13
Swelling/ Edema 9 9
Purulent Discharge 9 9
Skin Infection 8 8
Ambulation Difficulties 7 7
Bacterial Infection 7 7
Erythema 7 7
Inflammation 5 5
Cellulitis 5 5
Fever 5 5
Pneumothorax 3 3
Sepsis 3 3
Abscess 3 3
Foreign Body In Patient 3 3
Low Blood Pressure/ Hypotension 2 2
Convulsion/Seizure 2 2
Nodule 2 2
Confusion/ Disorientation 2 2
Burning Sensation 2 2
Numbness 2 2
Device Embedded In Tissue or Plaque 1 1
Arthritis 1 1
Respiratory Failure 1 1
Inadequate Pain Relief 1 1
Subcutaneous Nodule 1 1
Bradycardia 1 1
Renal Impairment 1 1
Paresis 1 1
Laceration(s) 1 1
Insufficient Information 1 1
Pleural Effusion 1 1
Urinary Retention 1 1
Exposure to Body Fluids 1 1
Neck Pain 1 1
Burn(s) 1 1
Skin Erosion 1 1
Paralysis 1 1
Needle Stick/Puncture 1 1
Device Overstimulation of Tissue 1 1
Post Operative Wound Infection 1 1
Itching Sensation 1 1
Blister 1 1
Muscle Weakness 1 1
Hematoma 1 1
Presyncope 1 1
Fatigue 1 1
Shock from Patient Lead(s) 1 1

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