BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 13677581 · Received March 5, 2022

    Report

    Report Number
    3006630150-2022-00860
    Event Type
    Injury
    Date Received
    March 5, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7072604.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF STIMULATION IN THE TARGETED LOW BACK AND LOWER LEG AREAS, AND INSTEAD FELT STIMULATION IN THE MID-TORSO. X-RAY IMAGING TAKEN IN THE FIELD REVEALED THE LEADS HAD MIGRATED. ATTEMPTS TO REPROGRAM THE DEVICE WERE UNSUCCESSFUL, AND THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE MOVED BACK INTO THEIR ORIGINAL POSITION. THE PATIENT DID WELL POST-OPERATIVELY AND STIMULATION WAS RESTORED TO THE INTENDED LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177233 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7072352 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention