BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 23854879 · Received December 19, 2025

    Report

    Report Number
    3006630150-2025-11564
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    January 1, 2022
    Report Date
    December 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, APPROXIMATE EVENT DATE SINCE PATIENT HAS HAD NO PAIN RELIEF OVER THE LAST 2-3 YEARS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7071827, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7071979, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT EXPLANTATION OF THE IPG AND LEADS DUE TO LACK OF PAIN RELIEF. POSTOPERATIVELY, THE PATIENT IS RECOVERING WITHOUT COMPLICATIONS. THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR ANALYSIS, AS THE MEDICAL FACILITY DOES NOT RELEASE CONTAMINATED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2345008 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 373246 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention