BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6039770 · Received October 19, 2016

    Report

    Report Number
    3004209178-2016-22060
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 25, 2016
    Report Date
    January 24, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 HEALTH CARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT ON THE NIGHT PRIOR TO THE DATE OF THIS REPORT, THEY WERE ATTEMPTING TO PROGRAM THE DEVICE OFF, BUT WHEN THE GRAY POWER BUTTON WAS PRESSED, THERE WAS NO "BUZZ" AND THE IMPLANTABLE NEUROSTIMULATOR (INS) DIDN'T TURN OFF. IT WAS ALSO STATED THAT DURING THIS TIME, A POOR COMMUNICATION SCREEN WAS DISPLAYED SO THEY MOVED THE PROGRAMMER AROUND, BUT THE POOR COMMUNICATION WAS NOT RESOLVED. IT WAS CONFIRMED THAT THE PATIENT PROGRAMMER SEEMED TO BE FUNCTIONING NORMALLY BUT THE PATIENT DOES NOT USE AN ANTENNA. TROUBLESHOOTING WAS PERFORMED, BUT WAS LIMITED DUE TO A LACK OF ACCESS TO THE PATIENT PROGRAMMER. NO SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    A FRIEND OR FAMILY MEMBER OF THE PATIENT REPORTED THAT IN (B)(6) 2016 THE PATIENT HAD TRIED ALL GROUPS (A, B, C, D, E) AND WERE DOING WELL ON THEIR CURRENT SETTING UNTIL THE HCP MADE ADJUSTMENTS ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691584 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR