BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1963675 · Received December 21, 2010

    Report

    Report Number
    1723170-2010-00209
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE FRAZIER SUCTION SHOWED AN INACCURACY 1 CM TO THE RIGHT. THE PASSIVE PLANAR BLUNT WAS ACCURATE. THEY ATTEMPTED TO RE-VERIFY THE SUCTION AND COULD NOT GET IT TO BE MORE ACCURATE. THE SURGEON SUCCESSFULLY COMPLETED SURGERY USING THE STEALTHSTATION WITH NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR