BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19418453 · Received May 29, 2024

    Report

    Report Number
    3006630150-2024-03458
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    May 5, 2024
    Report Date
    May 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7080039/7080035.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG SITE HAD OPENED UP. THE PATIENT WAS ADMITTED IN THE HOSPITAL AND WAS KEPT ON INTRAVENOUS ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED AND NOT RETURNED. NO DEVICE MALFUNCTION SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825226 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 591129

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R