BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 22115601 · Received May 30, 2025

    Report

    Report Number
    3006630150-2025-03805
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    January 10, 2025
    Report Date
    May 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: 7083487/7083540. UDI: (B)(4). UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION-MRI UPN: M365SC43190. MODEL: SC-4319. SERIAL: NA BATCH: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE THE PATIENT DEVELOPED AN INFECTION. THE PHYSICIAN BELIEVED IT WAS DEVICE AND PROCEDURE RELATED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26514 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 758146 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention