BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25095772 · Received May 6, 2026

    Report

    Report Number
    3006630150-2026-02926
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EXPLANT DATE USED AS THE APPROXIMATED DATE OF EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-8352-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7070887. MODEL/CATALOG DESCRIPTION: COVEREDGE X 32 SURGICAL LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE MIDLINE INCISION WHICH CAUSED DRAINAGE, FEVER AND PAIN. THE PATIENT WAS PROVIDED WITH ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISPOSED OF BY THE FACILITY. CULTURES WERE TAKEN AND THE RESULTS REVEALED POSITIVE FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499901 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 816637 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention