BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3180622 · Received June 20, 2013

    Report

    Report Number
    3007566237-2013-02041
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ONLY LASTED 8 MONTHS. ALL IMPEDANCES WERE REPORTED TO BE BETWEEN 750 AND 1800 OHMS, THE THERAPY IMPEDANCE WAS UNKNOWN. ESTIMATED LONGEVITY CALCULATIONS WERE USED WITH BOTH GROUPS THE PATIENT HAD. IT WAS UNKNOWN WHICH GROUP WAS USED MORE OFTEN (GROUP 1: L: 3.4V, 180US, 250HZ, 6+, 5-, 1250 OHMS; R: 2.8V, 150US, 250 HZ, 1+, 0-, 1250 OHMS, ERI 16 MONTHS, EOS 18.5 MONTHS) (GROUP 2: L: 1.8V, 150US, 250HZ, C+, 0-, 1250 OHMS; R: 2.3V, 150US, 250 HZ, C+, 5-, 1250 OHMS, ERI 2.8 YEARS, EOS 3 YEARS). ADDITIONAL INFORMATION WAS REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281563 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1