BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7268538 · Received February 13, 2018

    Report

    Report Number
    3004209178-2018-03251
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    February 9, 2018
    Report Date
    February 13, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT'S THERAPY WAS CHANGING FROM GROUP B TO GROUP A AT 12:15 AM EACH DAY, WHILE THE PATIENT WAS SLEEPING. DAILY ACTIVITY SHOWED THE PATIENT WAS GOING FROM GROUP B TO GROUP A, BUT NEVER FROM GROUP A TO GROUP B. THE HCP INDICATED THEY WOULD GET MEDTRONIC DATA AT THEIR NEXT VISIT WITH THE PATIENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111273 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR