BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV THORACIC PROBE TIP

    MDR report key: 2191065 · Received July 19, 2011

    Report

    Report Number
    1723170-2011-01250
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE WAS UNK AS NO LOT NUMBER WAS PROVIDED. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE NAVLOCK PROBE TIP BENT DURING A CASE. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAV THORACIC PROBE TIP STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR