BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2040342 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00652
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 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

    MEDTRONIC REP RE-SEATED/TIGHTENED ALL VIDEO CABLES ON COMPUTER AND VIDEO SPLITTER. LEFT SYSTEM RUNNING FOR 7 HOURS AND CHECKED AGAIN. VIDEO WAS STILL WORKING. COULDN'T DUPLICATE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REP RECEIVED A REPORT THAT THE SURGEON MONITOR WENT BLACK DURING CASE. UNPLUG/RE-PLUG DID NOT CORRECT THE ISSUE. POWERING DOWN (HARD-BOOT) AND RE-BOOTING DID SOLVE THE ISSUE. CASE WAS ABLE TO PROCEED WITH NO EFFECT ON PT AS ALL SCANS AND REGISTRATION WERE RETAINED. THE MEDTRONIC REP HAD CONFIRMED PROPER FUNCTIONALITY PRIOR TO THE CASE, BUT WAS NOT PRESENT DURING FAILURE. THE SURGEON COMPLETED THE SURGERY 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 S7 SYSTEM STEROTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR