BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20040729 · Received August 22, 2024

    Report

    Report Number
    3006630150-2024-05502
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7079462. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7138985/7140248.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO A LOT OF PAIN AS ONE OF THE SPINAL CORD STIMULATION (SCS) LEADS RUBBED THROUGH THE BACK AND PUNCTURED THE SKIN. ABOUT ONE INCH OF THE LEAD WAS HANGING OUTSIDE THE PATIENTS BODY, WHICH STARTED AS A BLISTER AND THEN IT RUPTURED THROUGH SKIN. THE PATIENT WAS PLACED ON ANTIBIOTICS TO AVOID FUTURE INFECTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072829 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7078547 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention