BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 25225526 · Received May 19, 2026

    Report

    Report Number
    3006630150-2026-03315
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    December 26, 2025
    Report Date
    May 19, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO MONTHS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50 . SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5042087 / 7072707. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM . UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318 . BATCH/LOT NUMBER: 25949814 . MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT . UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALL COMPONENTS WERE EXPLANTED DUE TO INADEQUATE STIMULATION. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY, AND PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358335 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 373054 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1