BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2193521 · Received July 21, 2011

    Report

    Report Number
    1723170-2011-01240
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT PART SHIPPED (B)(6) 2011. MEDTRONIC REPRESENTATIVE REPORTS THAT HE REPLACED THE CAMERA AND THE SYSTEM IS TRACKING NORMALLY.

    Description of Event or Problem · 1

    A NEURO COORDINATOR AT THE SITE REPORTED THAT THE CAMERA IS CYCLING ON THEIR STEALTHSTATION TREON GUIDANCE SYSTEM. THE CAMERA BEEPS 5-6 TIMES, STOPS, THEN BEEPS CONSTANTLY. THE SYSTEM DISPLAYS BLACK STATUS IN THE CRANIAL APPLICATION. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PATIENT 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