BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 24333893 · Received February 13, 2026

    Report

    Report Number
    3004209178-2026-02399
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 18, 2026
    Report Date
    February 13, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000564346
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 IS FREEZING A LOT. CALLER SAID THEY WERE TRYING TO TRIM THE PATIENTS TOE NAIL AND THE PATIENT'S FEET WERE MOVING. PATIENT IS VERY UNSTABLE ON THEIR FEET AND SLEEPS MORE THAN THEY SHOULD. PATIENT HAS AN APPOINTMENT W/ THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2026. REVIEWED HOW TO CHECK THE INSS. CALLER SAW COMMUNICATOR NOT FOUND WHICH WAS RESOLVED BY RESETTING THE COMMUNICATOR. CALLER CHECKED THE RIGHT SIDE IMPLANT AND THERAPY WAS ON AND INS WAS CHARGED TO 80%. CALLER CHECKED THE LEFT SIDE AND THERAPY WAS OFF AND THE INS CHARGED TO 50%. REVIEWED HOW TO TURN THERAPY ON. CALLER WAS ABLE TO TURN THE LEFT SIDE ON. CALLER SAID THEY WERE TOLD THEY COULD CHARGE BOTH INSS AT THE SAME TIME AS THEY HAVE 2 WR. CALLER WAS ABLE TO STARTED A CHARGING SESSION ON THE RIGHT SIDE. THE LEFT SIDE CONNECTED TO THE INS BUT THE RECHARGER APP SHOWED OPEN LOOP CHARGING THEN THE POWER LIGHT WENT RED. C ALLER SAID ONCE THE RIGHT SIDE GETS TO 100% THEY CHARGE THE LEFT SIDE. CALLER ALSO MENTIONED THE PATIENT IS URINATING FREQUENTLY BUT DOES NOT HAVE A UTI AS IT DOESN'T BURN WHEN THEY URINATE. CALLER ALSO MENTIONED A THERE WAS A TIME THE PATIENT "DROPPED" AT THEIR HOUSE AND THEY HAD TO USE THE LIFE ALERT AND THE PATIENT WAS TAKEN TO THE ER. CALLER BROUGHT THIS UP AS AN EXAMPLE OF THEIR CONCERN ABOUT ER STAFF NOT BEING FAMILIAR W/ THE DBS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398607 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. B35300 00763000564346

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male