BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19825383 · Received July 25, 2024

    Report

    Report Number
    3006630150-2024-04835
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7100040.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PATIENTS IMPLANT PROCEDURE, THE PHYSICIAN DID NOT LIKE THE WAY THE LEADS WERE REACTING. THE PHYSICIAN NOTED THAT THERE WAS NO ISSUE WITH LEAD PERFORMANCE, HOWEVER, IT WAS MORE OF AN ISSUE WITH PATIENTS ANATOMY. IMPEDANCE CHECK WAS DONE, AND MOST CONTACTS WERE REGISTERING ZERO. THE PHYSICIAN OPTED TO ABORT THE CASE AND REMOVE EVERYTHING OUT OF CONCERN FOR A HEMATOMA. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE REMOVED LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303849 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7097489 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention