BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 21770583 · Received April 4, 2025

    Report

    Report Number
    3006630150-2025-02138
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    December 2, 2024
    Report Date
    April 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: LINEAR 3-4. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7080611. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM WAS REPOSITIONED FROM THE RIGHT UPPER BUTTOCK TO RIGHT ABDOMEN DUE TO DISCOMFORT. IT WAS NOTED THAT ONE OF THE LEAD IN THE CLUNEAL AREA MIGRATED, WHICH WAS CONFIRMED WITH IMAGING, AND WAS EXPLANTED DURING THE PROCEDURE. SWELLING WAS NOTED, AND THE PATIENT WAS DOING WELL POST OPERATIVELY. NO DEVICES WILL BE RETURNED AS THE IPG REMAINED IMPLANTED, AND THE LEAD WAS DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301559 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 539461 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention