BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1011619 · Received March 10, 2008

    Report

    Report Number
    9614453-2008-01189
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 28, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. AS A RESULT OF AN INTERNAL AUDIT, THIS REPORT IS BEING SENT.

    Description of Event or Problem · 1

    INFO REC'D INDICATED THE DEVICE REACHED ENDO OF LIFE AFTER FOUR YRS IMPLANT DURATION. THE DEVICE FUNCTIONED CORRECTLY EXCEPT DURING FIVE OCCASIONS WHEN IT SWITCHED OFF SPONTANEOUSLY. THE PT WAS ABLE TO RESTART THE DEVICE WITH THE PT PROGRAMMER. THE DEVICE WAS REPLACED DUE TO END OF BATTERY LIFETIME. THE PT'S CURRENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC SWISS MANUFACTURING FACILITY 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK