BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION IOR SYSTEM

    MDR report key: 2632756 · Received June 26, 2012

    Report

    Report Number
    1723170-2012-00328
    Event Type
    Malfunction
    Date Received
    June 26, 2012
    Date of Event
    May 30, 2012
    Report Date
    May 30, 2012
    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

    PT WEIGHT IS UNK. UNABLE TO DETERMINE ROOT CAUSE WITHOUT FURTHER DETAILS ABOUT THE CASE. SUSPECT A CHANGE IN THE FRAME TO PT ORIENTATION SINCE ACCURACY CHECKPOINTS RESTORED ACCURACY. INSUFFICIENT INFO HAS BEEN PROVIDED IN ORDER TO ASCERTAIN PROBABLE CAUSE OF ALLEGED INACCURACY.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A TRASNPHENOIDAL CASE, AFTER THE TRANSITION FROM THE ENT PORTION TO THE NEURO PORTION, THE SURGEON FELT 3-4 MM INACCURATE. THEY HAD STORED ACCURACY CHECKPOINTS PRIOR TO BEGINNING TO NAVIGATE. THEY WENT BACK AND MATCHED THESE POINTS TO THE PT ANATOMY AND THIS RESTORED NAVIGATIONAL ACCURACY. CASE COMPLETED WITH USE OF NAVIGATION. NO NEGATIVE IMPACT TO PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR