BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD KIT FOR SPINAL STIMULATOR

    MDR report key: 19765200 · Received July 16, 2024

    Report

    Report Number
    MW5157347
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PATIENT'S SCHEDULED PROCEDURE OF IMPLANTATION OF SPINAL CORD STIMULATOR THE SURGEON DISCOVERED THAT THE SURGICAL LEAD KIT WAS NOT WORKING CORRECTLY. THE REPRESENTATIVE FROM BOSTON SCIENTIFIC, (B)(4), PROVIDED A NEW LEAD KIT AND WAS ABLE TO PAIR THE STIMULATOR DEVICE. THE KIT THAT WAS EXPLANTED WAS MODEL SC-8336-50 SERIAL NUMBER (B)(6), THIS WAS REPLACED WITH MODEL SC-8336-50, SERIAL NUMBER (B)(6) WITH NO INJURY OR DELAY TO THE PATIENT. THE EXPLANTED DEVICE WAS SENT WITH THE REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150448 LEAD KIT FOR SPINAL STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8336-50

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention