BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION IOR SYSTEM

    MDR report key: 2062980 · Received March 21, 2011

    Report

    Report Number
    1723170-2011-00688
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 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

    SOFTWARE INVESTIGATION COMPLETED AND SHOWED ACCURACY CHECKPOINTS WERE SET AND USED CORRECTLY TO REGAIN ACCURATE REGISTRATION AFTER THE IMRI ARM MOVEMENT CAUSED INACCURACIES. SOFTWARE FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE IMRI ARM MOVED DURING CRANIAL CASE CAUSING NAVIGATION TO BE INACCURATE. THE MEDTRONIC REPRESENTATIVE HAD THE SITE COMPLETE ACCURACY CHECKPOINTS AT THE BEGINNING OF THE CASE WHICH RESOLVED THE ISSUE AND CAUSED A 5 MINUTE DELAY IN THE CASE. THEY REALIGNED AND WERE ACCURATE. THE SURGEON COMPLETED THE CASE WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR