BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2193518 · Received July 21, 2011

    Report

    Report Number
    1723170-2011-01242
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 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

    PATIENT WEIGHT UNAVAILABLE FROM THE SITE. SOFTWARE INVESTIGATION COMPLETED. FINDINGS ARE THAT ADDITIONAL TRAINING, IN USING THE SYSTEM IS REQUIRED. A MEDTRONIC REPRESENTATIVE CONDUCTED TRAINING ON THE PROPER TECHNIQUE FOR ACQUIRING IMAGES FOR NAVIGATION, ON (B)(6) 2011, AT THE SITE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINE PROCEDURE, THE SITE WAS HAVING DIFFICULT ACTIVATING BOTH AP AND LATERAL IMAGES IN SYNERGY SPINE 1.7. HE STATED THAT THE EMPTY IMAGES WAS BRIGHT WHITE BUT HE WAS UNABLE TO SEE THE UN-ACTIVATED EMPTY IMAGE (WHAT THE DOTS LOOKED LIKE). THE SURGEON DISCONTINUED THE USE OF THE STEALTHSTATION S7 FOR NAVIGATION AND COMPLETED THE CASE SUCCESSFULLY. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR