BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 24351273 · Received February 16, 2026

    Report

    Report Number
    3004209178-2026-02546
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    February 13, 2026
    Report Date
    February 16, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MBX
    UDI-DI
    00763000564346
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT (PT) IS SCHEDULED FOR AN MRI TOMORROW MORNING AND WANTED AGENT TO WALK THEM THROUGH ACTIVATING MRI MODE. THE PATIENT THOUGHT THEIR HEALTHCARE PROVIDER (HCP) SENT AN MRI ELIGIBILITY REPORT TO THE MRI FACILITY, BUT THEY WEREN'T SURE. WHEN THE PATIENT TRIED TO ACTIVATE MRI MODE DURING THE CALL THEY GOT THE MESSAGE 'MRI MODE NOT AVAILABLE' WITH INFORMATION CODE 2610 2122 22 000. AGENT REVIEWED THAT THE INFORMATION CODE INDICATED THERE WAS AN OPEN CIRCUIT DETECTED. THE PATIENT WAS REDIRECTED TO THEIR MANAGING HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411826 PERCEPT Stimulator, thalamic, epilepsy, implanted MBX MEDTRONIC PUERTO RICO OPERATIONS CO. B35300 00763000564346

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male