BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 21022379 · Received December 26, 2024

    Report

    Report Number
    3006630150-2024-09018
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    May 20, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7081975/7082018.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD MILD TENDERNESS OVER THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND WAS NOT GETTING GOOD COVERAGE OF THE LOWER RIGHT LEG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS RELOCATED TO A MORE COMFORTABLE LOCATION AND THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437550 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 755621 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention