BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20417785 · Received October 10, 2024

    Report

    Report Number
    3006630150-2024-06835
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    May 17, 2024
    Report Date
    October 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7096698/7096700. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7081374/7083520.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT TO EMERGENCY ROOM (ER) DUE TO GETTING OVERSTIMULATED WITH THE SPINAL CORD STIMULATION (SCS). IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING PAIN IN THE UPPER BACK AND NECK WHENEVER THE SCS IS TURNED ON, INTENSIFIES THE PAIN AND CAUSED IT TO RADIATE DOWN THE ARMS. XRAY WAS TAKEN AND CONFIRMS THAT EVERYTHING LOOKS NORMAL. THE PHYSICIAN SUSPECTS THAT THE PAIN IS UNRELATED TO THE SCS. THE PATIENT UNDERWENT A SCS EXPLANT PROCEDURE, AND ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956544 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 531065 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention