BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 21108418 · Received January 8, 2025

    Report

    Report Number
    3006630150-2024-09361
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    October 22, 2024
    Report Date
    January 8, 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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336700, MODEL: SC-8336-70, SERIAL: (B)(6), BATCH: 7072730.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF DESPITE SEVERAL REPROGRAMMING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387283 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 570769 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention