BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 24365270 · Received February 17, 2026

    Report

    Report Number
    3006630150-2026-00936
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    December 16, 2025
    Report Date
    May 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9208150, MODEL: SC-9208-15, SERIAL: (B)(6), BATCH: 7070230 UDI: (B)(4). PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9208150, MODEL: SC-9208-15, SERIAL: (B)(6). BATCH: 7070196 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549783 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 370725 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention