BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 21023929 · Received December 26, 2024

    Report

    Report Number
    3006630150-2024-09044
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(6), BATCH: 7083399.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF AND WAS EXPERIENCING PAIN AT THE BATTERY SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE REMOVED AND NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190402 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 220622 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention