BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCI HANDLE

    MDR report key: 2062120 · Received March 17, 2011

    Report

    Report Number
    1723170-2011-00672
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K022126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. TESTING INDICATED THAT WITH MARKERS ATTACHED AND FULLY SEATED, THE PROBE RETURNED A HIGH GEOMETRY ERROR AS REPORTED. THE SUPPORT ARM FOR MARKER #2 IS BENT, CAUSING THE HIGH GEOMETRY ERROR.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT DURING A SHUNT PLACEMENT CASE, THE GEOMETRY ERROR OF A PCI PROBE WAS 0.60 AND THAT IT FLICKERED FROM GREEN TO RED STATUS. THE SURGEON WAS UNABLE TO USE THE PCI PROBE DURING THE CASE BUT WAS ABLE TO USE THE PASSIVE PLANAR BLUNT PROBE TO GET HIS TRAJECTORY FOR THE PROCEDURE. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PT WAS NOT AFFECTED BY THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCI HANDLE STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 203254

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR