BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 23241117 · Received October 7, 2025

    Report

    Report Number
    3006630150-2025-08532
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 UPN: M365SC2318700 MODEL: SC-2318-70 SERIAL: (B)(6) BATCH: 5003723 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2318700 MODEL: SC-2318-70 SERIAL: (B)(6) BATCH: 5004577 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION WHICH THE PHYSICIAN BELIEVED WAS NOT DEVICE OR PROCEDURE RELATED. THE PHYSICIAN INSPECTED AND CLEANED OUT BOTH THE MIDLINE AND POCKET INCISION SITES. NO HARDWARE WAS COMPROMISED OR REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND WAS ADMINISTERED WITH ANTIBIOTICS. THE DEVICE REMAINS IMPLANTED AND IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583914 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 796013

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention