BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19878689 · Received July 31, 2024

    Report

    Report Number
    3006630150-2024-05005
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    June 20, 2023
    Report Date
    July 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7079870 / 7080068.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND WAS HAVING DIFFICULTY IN CHARGING THE IPG DUE TO ITS PLACEMENT. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND WAS ONLY GETTING RIB STIMULATION DESPITE REPROGRAMMING ATTEMPTS. AN X-RAY WAS PERFORMED AND REVEALED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741009 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 573326

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention