BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 23641621 · Received November 25, 2025

    Report

    Report Number
    3006630150-2025-10786
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 29, 2025
    Report Date
    December 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED THE DAY THE SYSTEM WAS EXPLANTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS . UPN: M365SC2218500 . MODEL: SC-2218-50 . SERIAL: (B)(6). BATCH: 7122502/7090926. UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180 . MODEL: SC-4318 . BATCH: 27648348. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION. THE EXPLANTED PRODUCTS WERE DISCARDED PER HOSPITAL POLICY AND PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2825985 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 556807 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention