BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRAMELINK PLUS SOFTWARE

    MDR report key: 1696287 · Received May 20, 2010

    Report

    Report Number
    1723170-2010-00027
    Event Type
    Other
    Date Received
    May 20, 2010
    Date of Event
    March 31, 2009
    Report Date
    March 31, 2009
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K992927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SYSTEM NOR SCANS WERE RETURNED TO MEDTRONIC NAVIGATION FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A CASE USING MEDTRONIC NAVIGATION'S FRAMELINK SOFTWARE RESULTED IN THE LEAD PLACED 2.4 CM INFERIOR TO WHERE THEY EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAMELINK PLUS SOFTWARE STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other