BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24200893 · Received January 28, 2026

    Report

    Report Number
    3006630150-2026-00572
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    September 29, 2025
    Report Date
    May 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2318500 MODEL: SC-2318-50 SERIAL: (B)(6) BATCH: 5001763/5001921 UDI: (B)(4) UDI: (B)(4). PRODUCT FAMILY: SCS-RC-R UPN: M365SC557210 MODEL: SC-5572-1 SERIAL: (B)(6) BATCH: 547328 UDI: (B)(4). PRODUCT FAMILY: SCS-CHARGERS UPN: M365SC641230 MODEL: SC-6412-3 SERIAL: (B)(6) BATCH: 523230 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371799 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 796893 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1