BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2150595 · Received June 22, 2011

    Report

    Report Number
    1723170-2011-01133
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 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

    NO PT INFORMATION PROVIDED AS NO PT WAS PRESENT AT TIME OF EVENT. CONNECTED THE EMITTER AND IT COMMUNICATED WITH THE AXIEM WITHOUT ISSUE. DISCONNECTED AND RECONNECTED THE EMITTER 5 TIMES AND EACH TIME IT COMMUNICATED. THE EMITTER TRACKS THE INSTRUMENTS THROUGH THE ENTIRE FIELD. NO PROBLEMS FOUND. DID NOT CAUSE EVENT. THE COMMUNICATION CABLE CONNECTORS WERE FOUND TO HAVE DAMAGE, MAKING CONNECTION DIFFICULT. IT DID PASS TESTING AND CANNOT DEFINITIVELY BE CONSIDERED THE CAUSE OF THIS ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE THE SITE WAS PREPARING FOR A CASE, THE EMITTER WAS NOT COMMUNICATING. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    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