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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
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 4
SPR THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 1 1
2020 1 1
2021 6 6
2022 8 8
2023 25 25
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 34 34
Fracture 4 4
Difficult to Remove 2 2
Improper or Incorrect Procedure or Method 2 2
Activation, Positioning or Separation Problem 1 1
Biocompatibility 1 1
Break 1 1
Physical Resistance/Sticking 1 1
Migration or Expulsion of Device 1 1
Off-Label Use 1 1
Patient-Device Incompatibility 1 1
Unraveled Material 1 1
Difficult or Delayed Separation 1 1
Device Operates Differently Than Expected 1 1
Use of Device Problem 1 1
Retraction Problem 1 1
Unexpected Therapeutic Results 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 15 15
Skin Inflammation/ Irritation 11 11
Fluid Discharge 10 10
Skin Infection 8 8
Pain 8 8
Swelling/ Edema 6 6
Erythema 6 6
Ambulation Difficulties 5 5
Purulent Discharge 5 5
Inflammation 4 4
Bacterial Infection 4 4
Sepsis 3 3
Cellulitis 3 3
Fever 3 3
Foreign Body In Patient 3 3
Pneumothorax 2 2
Low Blood Pressure/ Hypotension 2 2
Hematoma 2 2
Confusion/ Disorientation 2 2
Convulsion/Seizure 2 2
Burning Sensation 2 2
Nodule 2 2
Numbness 2 2
Device Embedded In Tissue or Plaque 1 1
Respiratory Failure 1 1
Subcutaneous Nodule 1 1
Inadequate Pain Relief 1 1
Hemorrhage/Bleeding 1 1
Partial thickness (Second Degree) Burn 1 1
Bradycardia 1 1
Abscess 1 1
Renal Impairment 1 1
Paresis 1 1
Laceration(s) 1 1
Insufficient Information 1 1
Urinary Retention 1 1
Pleural Effusion 1 1
Exposure to Body Fluids 1 1
Needle Stick/Puncture 1 1
Neck Pain 1 1
Skin Erosion 1 1
Paralysis 1 1
Burn(s) 1 1
Post Operative Wound Infection 1 1
Blister 1 1
Muscle Weakness 1 1
Presyncope 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Shock from Patient Lead(s) 1 1
Emotional Changes 1 1

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