BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 24293999 · Received February 9, 2026

    Report

    Report Number
    3004209178-2026-02105
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    February 6, 2026
    Report Date
    February 9, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000916268
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CALLER WAS TRYING TO PUT IMPLANTED NEUROSTIMULATORS INTO MRI MODE. THE RIGHT IMPLANTED NEUROSTIMULATOR WENT INTO MRI MODE BUT THE LEFT IMPLANTED NEUROSTIMULATOR DISPLAYED "MRI MODE NOT AVAILABLE" WITH INFORMATION CODE 2511 2122 22 000. AGENT REVIEWED THAT AN OPEN CIRCUIT WAS DETECTED DURING THE TEST. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358506 PERCEPT Stimulator, electrical, implanted, for parkinsonian tremor MHY MEDTRONIC PUERTO RICO OPERATIONS CO. B35200 00763000916268

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female