BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION MONTAGE MRI

    MDR report key: 17629289 · Received August 28, 2023

    Report

    Report Number
    3006630150-2023-05094
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    March 30, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905943
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7093991/7089841.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN EMERGENT MRI, AND THE DEVICE WAS NOT PROPERLY TURNED OFF OR PLACED IN MRI MODE. PER PATIENT, EVER SINCE THEN THE IPG WAS OVERHEATING AND HAD LOSS OF STIMULATION. IT WAS ALSO NOTED THAT THE PATIENTS LEADS WERE FRACTURED AND ALL CONTACTS ON THE RIGHT LEAD ARE COMPLETELY OUT AND WAS UNABLE TO ACHIEVE BACK COVERAGE AND WAS RECEIVING UNDESIRED SENSATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317779 PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1200 373695 08714729905943

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention