BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 24084767 · Received January 15, 2026

    Report

    Report Number
    3004209178-2026-00752
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 8, 2025
    Report Date
    January 15, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000100360
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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 PATIENT (PT) SAW A 626 CODE ON THEIR THERAPY APP LAST WEEK AND SAID IT DIDN'T SEEM LIKE THE IMPLANT WAS CHARGING. PATIENT SAID THEY CHARGED THEIR IMPLANT EVERY NIGHT. AGENT REVIEWED THIS MEANT IMPLANT BATTERY WAS LOW. AGENT REVIEWED FOR PATIENT TO CHARGE IMPLANT UP AND REVIEWED RECHARGER DURATION EXPECTATIONS. AGENT REVIEWED HOW TO CHARGE IMPLANT. DURING CALL PATIENT WAS ABLE TO START IMPLANT CHARGING SESSION. IT SOUNDED LIKE THE WIRELESS RECHARGER WOULD CONNECT AND THEN DISCONNECT AFTER A COUPLE MINUTES. AGENT ASKED IF PATIENT HAD HANDSET TO CHECK RECHARGER APP BUT PATIENT WAS UNINTELLIGIBLE. AGENT REVIEWED THAT PATIENT COULD TRY HARD RESET ON WIRELESS RECHARGER BUT IT DID NOT SEEM LIKE PATIENT WAS ABLE TO DO THIS. PATIENT WAS SO HARD TO UNDERSTAND THAT AGENT RECOMMENDED THAT PATIENT CALL BACK IN WITH ASSISTANCE. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE. AG ENT ASKED PATIENT WHO THEIR MANAGING PHYSICIAN WAS AND PATIENT DID NOT ANSWER. THE PATIENT CALLED BACK TO REPORT THAT THEY CHARGED THE INS A LITTLE BIT LAST NIGHT AND WANTED TO CHECK THE INS BATTERY LEVEL. AGENT MANAGED TO INSTRUCT THE PATIENT TO TURN ON THE WIRELESS RECHARGER AND POSITION IT OVER THEIR INS, THEN OPEN THE RECHARGER APP. THE PATIENT COULD THEN SEE THAT THE INS BATTERY WAS 75% CHARGED, THERAPY WAS ON, AND THE WIRELESS RECHARGER HAD AN EXCELLENT CONNECTION WITH THE INS. AGENT REVIEWED THAT THE EQUIPMENT WAS WORKING AS EXPECTED, AND THE PATIENT DID NOT REQUIRE FURTHER ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148979 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00763000100360

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male