BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2062984 · Received March 21, 2011

    Report

    Report Number
    1723170-2011-00692
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SHOWED THAT THE SITE PUT THE REFERENCE FRAME ON BACKWARDS AFTER GOING STERILE. PATIENT HAD TO BE CLOSED, RE-DRAPED AND RE-REGISTERED TO COMPLETE THE CASE WHICH IS A REVISION SURGERY.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT DURING A CRANIAL CASE, THE STEALTHSTATION TREON GUIDANCE SYSTEM WOULD NOT SHOW RED CROSS HAIRS IN THE NAVIGATION SCREEN. HE WAS UNABLE TO CONFIRM BUT BELIEVED THE CRANIAL REFERENCE FRAME AND THE PASSIVE PLANAR BLUNT PROBE WERE GREEN BUT THE CROSS HAIRS WERE RED. THE SURGEON REGISTERED THE PATIENT WITH A 1.1 ACCURACY. PROCEEDED ON TO NAVIGATION TO CHECK HIS ACCURACY AND COULD NOT GET HIS CROSS HAIRS TO GO GREEN. THE SITE REPRESENTATIVE SAID HE RE-BOOTED THE SYSTEM AND THEY WENT BACK INTO NAVIGATION, BUT THE ACCURACY WAS OFF BY 20 CM. THE SURGEON OPTED TO CONTINUE THE SURGERY WITHOUT THE USE OF THE STEALTHSTATION. THERE WAS 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 43 YR