BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8089473 · Received November 20, 2018

    Report

    Report Number
    3004209178-2018-25819
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    November 16, 2018
    Report Date
    January 17, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT INDICATING THAT THE CAUSE OF THE THERAPY BEING OFF WAS DUE TO A POWER SURGE AND PRESSING A WRONG BUTTON THE DEEP BRAIN STIMULATOR. TURNING THE THERAPY BACK ON RESOLVED THE TREMORS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THERE WAS A POWER OUTAGE ON THURSDAY OR FRIDAY AND OVER THE WEEKEND IT WAS DETERMINED THAT THE PATIENT'S DEVICE WAS NOT WORKING, AND PATIENT WAS BEGINNING. TO HAVE TREMORS. THE CALLER TRIED TO REACH THE PATIENT'S DOCTOR OVER THE WEEKEND AND COULD NOT. THE CALLER REPORTS SEEING PHYSICIAN RECHARGER INFORMATION SCREEN, THE CALLER READ FROM THE MANUAL WHAT IT MEANS "AN INCORRECT COMBINATION OF KEYS WAS PRESSED AND AN ERROR HAS OCCURRED. THE RECHARGER CANNOT BE USED TO CHARGE YOUR NEUROSTIMULATOR. CONTACT YOUR PHYSICIAN." THE CALLER WAS WALKED THROUGH RESETTING THE RECHARGER AND THEN SHE WAS ABLE TO PLUG IT IN AND GET THAT CHARGING. THE CALLER THEN INDICATED THAT THE RECHARGER WAS NOT THE ITEM ENCOUNTERING ISSUES, IT WAS THE PATIENT PROGRAMMER (PP). THE HCP WAS WALKED THROUGH A HARD RESET OF THE CONTROLLER, AND THE CALLER REPLACED THE BATTERIES WITH BRAND NEW. THE CALLER WAS THEN ABLE TO USE THE PP AND DETERMINED THAT THE THERAPY WAS TURNED OFF. THE HCP WAS WALKED THROUGH TURNING THE DEVICE BACK ON, AND IT INDICATED THAT THE BATTERY LEVEL IS OK. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928392 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR