BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1202483 · Received August 8, 2008

    Report

    Report Number
    2182207-2008-04827
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    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

    Description of Event or Problem · 1

    IMPEDANCE READING >4000 OHMS WAS REPORTED ON ALL OR SOME OF THE BIPOLAR PAIRS. THE AMPLITUDE WAS INCREASED TO 2.5 VOLTS. IMPEDANCES WERE NORMAL. THE PATIENT HAD AN MRI BY PROTOCOL. NO X-RAY WAS TAKEN. NO FURTHER REPROGRAMMING OR TROUBLESHOOTING WAS PERFORMED. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1