BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 21381973 · Received February 13, 2025

    Report

    Report Number
    3006630150-2025-00716
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    January 1, 2024
    Report Date
    February 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN THE YEAR OF 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: M365SC8416500, MODEL: SC-8416-50, SERIAL: (B)(6), BATCH: 7032517.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) DEVICE STOPPED WORKING AND WAS NOT PROVIDING PAIN RELIEF. THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414644 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 21490233

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention