BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN MRI

    MDR report key: 20741081 · Received November 20, 2024

    Report

    Report Number
    3006630150-2024-08011
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    January 23, 2024
    Report Date
    November 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951131
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI UPN: M365SC8416700, MODEL: SC-8416-70, SERIAL: (B)(6), BATCH: 7070715.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR PADDLE LEAD HAD IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR PADDLE LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430118 ARTISAN MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-8416-70 7070232 08714729951131

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention