BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 16576904 · Received March 20, 2023

    Report

    Report Number
    3006630150-2023-01396
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    January 25, 2022
    Report Date
    March 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7090024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DID NOT HAVE GOOD COVERAGE DESPITE MULTIPLE EXTENSIVE REPROGRAMMING. LEAD MIGRATION WAS CONFIRMED UNDER FLUOROSCOPY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955850 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7090006 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention