BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? PRIME

    MDR report key: 21869848 · Received April 19, 2025

    Report

    Report Number
    3006630150-2025-02627
    Event Type
    Injury
    Date Received
    April 19, 2025
    Date of Event
    July 31, 2023
    Report Date
    April 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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: 7080488, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS-MRI UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7080469, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NO LONGER GETTING ADEQUATE PAIN RELIEF DESPITE OF OPTIMIZING THE PROGRAM. X-RAY SHOWED THAT THE LEAD HAD SHIFTED TO THE LEFT. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732772 WAVEWRITER ALPHA? PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1432 212045 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention