BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17446469 · Received August 2, 2023

    Report

    Report Number
    3006630150-2023-04518
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    April 12, 2023
    Report Date
    August 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED 3 MONTHS AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7082377.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REVISED AND REMAIN IMPLANTED IN THE PATIENT. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481586 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7081606 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention