BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 16900840 · Received May 10, 2023

    Report

    Report Number
    3006630150-2023-02546
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    September 10, 2022
    Report Date
    May 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED 6 MONTHS AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 5031938/5031778.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FREQUENTLY CHARGING THE IPG. IT WAS ALSO NOTED THAT THE LEAD HAD HIGH IMPEDANCES THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE OLD SYSTEM WAS REPLACED WITH A MAGNETIC RESONANCE IMAGING (MRI) CAPABLE ONE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226962 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 339726 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention