BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20377718 · Received October 4, 2024

    Report

    Report Number
    3006630150-2024-06707
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    April 15, 2024
    Report Date
    October 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED MID-APRIL 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: M365SC2218700 UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6) BATCH: 7090658.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF PAIN RELIEF. MULTIPLE REPROGRAMMING'S WERE MADE HOWEVER FAILED TO REGAIN COVERAGE. IMAGING WAS TAKEN, AND SPINAL CORD STIMULATION (SCS) LEAD MIGRATION WAS CONFIRMED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443612 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7090653 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention