BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PISCES QUAD PLUS

    MDR report key: 1926387 · Received November 11, 2010

    Report

    Report Number
    3007566237-2010-09244
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 22, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K923567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE WAS OVER 4000. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PISCES QUAD PLUS GZB MEDTRONIC NEUROMODULATION 3888 B0804431K

    Patients

    Seq Age Sex Outcome Treatment
    1