BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 21397016 · Received February 18, 2025

    Report

    Report Number
    3006630150-2025-00777
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 23, 2025
    Report Date
    February 16, 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
    TN, 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: M365SC2318500, MODEL: SC-2318-50, SERIAL: (B)(6), BATCH: 5002660 / 5002677. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, SERIAL: NA, BATCH: 35501114.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NEW PAIN IN RIGHT FOOT THAT PROGRESSIVELY GOT WORSE OVER THE SPAN OF TWO HOURS AFTER IMPLANTATION. THE PHYSICIAN BELIEVED THAT THE NEW PAIN WAS PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED AND PATIENT FELT BETTER POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208648 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 777116 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention