BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 25137971 · Received May 11, 2026

    Report

    Report Number
    3004209178-2026-08021
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 11, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000564346
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 THE PATIENT WAS TRYING TO ACTIVATE MRI MODE, BUT THE PROGRESS BAR ON THE 'COMMUNICATING WITH DEVICE' SCREEN KEPT GETTING STUCK AT 100%. THE PATIENT CONFIRMED THE COMMUNICATOR WAS CLOSE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) AND HANDSET. THE SCREEN CHANGED TO 'PLACE THE COMMUNICATOR OVER THE NEUROSTIMULATOR AND PRESS CONNECT.' THE PATIENT DID AS ADVISED, THEN THE SCREEN EVENTUALLY ADVANCED TO THE HOME SCREEN OF THE MY DBS THERAPY APP AND THEY COULD SEE THE INS BATTERY WAS 100% CHARGED. THE PATIENT DID NOT HAVE AN MRI ELIGIBILITY REPORT, SO THEY TESTED THE SYSTEM BUT IT CAME BACK AS 'MRI MODE IS NOT AVAILABLE' WITH INFORMATION CODE 2621 2122 22 000. AGENT REVIEWED THAT THE CODE INDICATED THERE WAS AN OPEN CIRCUIT DETECTED, WHICH SURPRISED THE PATIENT SINCE THEY WERE JUST AT THEIR HCP'S OFFICE LAST WEEK. THE PATIENT WAS REDIRECTED TO THEIR HCP TO FURTHER ADDRESS THE ISSUE. THE PATIENT MENTIONED THAT THEY CAN NEVER POWER OFF THE COMMUNICATOR TO GET IT TO HOLD A CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187192 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. B35300 00763000564346

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female