BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 19728403 · Received July 12, 2024

    Report

    Report Number
    3006630150-2024-04497
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7080176.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE LEADS WOULD BE REVISED BECAUSE IT HAD MIGRATED DUE TO A FALL. DURING THE PROCEDURE, THERE WAS TOO MUCH COIL IN THE LEAD FOR THE STYLET TO ADVANCE FULLY. THE PHYSICIAN ATTEMPTED TO RETRACT THE STYLET, BUT IT CAUGHT THE LEAD, RESULTING IN DAMAGE TO THE LEAD TAIL. CONSEQUENTLY, THE LEADS WERE REPLACED. THE PATIENT WAS DOING POSTOPERATIVELY, AND THE EXPLANTED LEADS WILL NOT BE RETURNED, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236428 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7080171 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention