BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3134055 · Received May 29, 2013

    Report

    Report Number
    1723170-2013-00384
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. A MEDTRONIC REPRESENTATIVE, AT THE SITE, REPLACED THE COMM POWER CABLE (B)(4) 2013. UPON STARTING UP THE SYSTEM, THE ERROR MESSAGE WAS GONE AND THE CAMERA WAS NO LONGER POWER CYCLING. ISSUE RESOLVED. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICES FINDS THE FISCHER CONNECTOR IS DAMAGED IN AN OUT-OF-ROUND CONDITION THAT WILL NOT ALLOW CONNECTION TO THE MATING PART. A CONTINUITY TEST REVEALED AN OPEN FROM PIN 5 OF THE FISCHER CONNECTOR TO PIN 2 OF THE DB9 CONNECTOR. THE RED WIRE WITHIN THE FISCHER CONNECTOR HAD BEEN PULLED FROM THE PIN. THIS ELECTRICAL ISSUE DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, REGISTERED NURSE, REPORTED THAT UPON TURNING ON THEIR NAVIGATION SYSTEM, PRIOR TO A CRANIAL PROCEDURE, THE CAMERA WAS BEEPING INTERMITTENTLY. IN TROUBLE-SHOOTING, THE SYSTEM WAS RE-BOOTED AND EXTERNAL PSU CABLES WERE CHECK FOR DAMAGE; THE BEEPING CONTINUED FOR A SHORT PERIOD THEN STOPPED. AS THEY COULD SEE THE GEOMETRY OF THE REFERENCE FRAME AND THERE WERE NO FURTHER ISSUES, THE SYSTEM WAS DETERMINED TO BE FUNCTIONING PROPERLY. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237106 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1