BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22476062 · Received July 10, 2025

    Report

    Report Number
    3006630150-2025-05398
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    August 28, 2024
    Report Date
    September 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: COVEREDGE? X 32. UPN: M365SC8352500. MODEL: SC-8352-50. SERIAL: (B)(6). BATCH: 7070592. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: COVEREDGE? X 32, UPN: M365SC8352500, MODEL: SC-8352-50, SERIAL: (B)(6), BATCH: 7070592, UDI: (B)(4). THE IPG AND PADDLE LEAD WERE RETURNED, ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. A LABELING REVIEW WAS PERFORMED ON THE DEVICES INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. IT STATES UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS, AND/OR LEAD FAILURE ARE KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE DEVICES WERE RETURNED AS SUCH PHYSICAL ANALYSIS WAS CONDUCTED, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS ABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THE COMPLAINT AS KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLADDER INCONTINENCE AND BELIEVES THE SPINAL CORD STIMULATOR (SCS) SYSTEM IS THE CAUSE AND REQUESTED AN EXPLANT OF THE SYSTEM. IMAGING WAS PERFORMED AND PER THE PHYSICIANS' ASSESSMENT LEAD PLACEMENT IS NOT CONTRIBUTING TO THE PATIENTS' SYMPTOMS. THE PATIENT UNDERWENT A SYSTEM EXPLANT AND IS DOING WELL POST OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLADDER INCONTINENCE AND BELIEVES THE SPINAL CORD STIMULATOR (SCS) SYSTEM IS THE CAUSE AND REQUESTED AN EXPLANT OF THE SYSTEM. IMAGING WAS PERFORMED AND PER THE PHYSICIANS' ASSESSMENT LEAD PLACEMENT IS NOT CONTRIBUTING TO THE PATIENTS' SYMPTOMS. THE PATIENT UNDERWENT A SYSTEM EXPLANT AND IS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873431 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 599211 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention