BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION? MONTAGE? MRI

    MDR report key: 24991739 · Received April 25, 2026

    Report

    Report Number
    3006630150-2026-02629
    Event Type
    Injury
    Date Received
    April 25, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: MODEL NUMBER/CATALOG NUMBER: SC-8416-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7073481. MODEL/CATALOG DESCRIPTION: ARTISAN MRI PADDLE LEAD 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) HAD MIGRATED AND THE PATIENT EXPERIENCED A DISCOMFORT DUE TO ITS POSITION AND HAD AN INADEQUATE STIMULATION. ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542466 PRECISION? MONTAGE? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1200 374842

    Patients

    Seq Age Sex Outcome Treatment
    1