BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5710293 · Received June 9, 2016

    Report

    Report Number
    3004209178-2016-11230
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    May 17, 2016
    Report Date
    June 9, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED IMPEDANCE MEASUREMENTS WERE RUN AT 3V AND PAIRS WITH ELECTRODE 8 WERE HIGH: C/8 26823 OHMS, 8/9 24675 OHMS, 8/10 23908 OHMS AND 8/11 23724 OHMS. EVERY OTHER PAIR WAS UNDER 2,000 OHMS. THE PATIENT WAS GETTING GOOD THERAPY WITH PROGRAMMING THAT INCLUDED ELECTRODE 8 USING AMPLITUDE OF 5V. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365535 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR