BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 21372873 · Received February 13, 2025

    Report

    Report Number
    3006630150-2025-00676
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED APPROXIMATELY ON THE DATE OF EXPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS . UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7071247. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43160. MODEL: SC-4316. SERIAL: NA. BATCH: 25329550.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97836 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 365814 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention