BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 17671566 · Received September 1, 2023

    Report

    Report Number
    3006630150-2023-05241
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    July 27, 2022
    Report Date
    September 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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)(6). BATCH: 7073339.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT X-RAY IMAGING TAKEN IN THE FIELD REVEALED THE ONE OF THE TWO IMPLANTED SPINAL CORD STIMULATION (SCS) LEADS HAD MIGRATED OUTSIDE THE EPIDURAL SPACE. REPROGRAMMING EFFORTS WERE SUCCESSFUL, AND THE PATIENT RECEIVED ADEQUATE PAIN COVERAGE FROM THE LEAD THAT HAD NOT MIGRATED. HOWEVER, THE PATIENT WAS IN NEED OF MAGNETIC RESONANCE IMAGING (MRI) AND UNDERWENT A REVISION PROCEDURE WHERE THE MIGRATED LEAD WAS REPLACED. THE PATIENT DID WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS RETAINED BY THE FACILITY; AS SUCH, ANALYSIS COULD NOT BE CONDUCTED IN OUR LABORATORY AND THE SERIAL NUMBER OF THE EXPLANTED LEAD COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513867 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 7073333 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention