BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 19023315 · Received April 2, 2024

    Report

    Report Number
    3006630150-2024-02016
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    September 13, 2023
    Report Date
    April 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    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

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED APPROXIMATELY THREE WEEKS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8216700. MODEL: SC-8216-70. SERIAL: (B)(6). BATCH: 7032458.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS IPG WAS TURNING ON AND OFF AT RANDOM TIMES AND WOULD EXPERIENCE AN INTENSE STIMULATION WHEN THE DEVICE WAS ON. THE PATIENTS LEAD ALSO HAD HIGH IMPEDANCE AND WAS EXPERIENCING INADEQUATE COVERAGE OF PAIN AREAS. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517035 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 358158 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention