BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2152440 · Received June 28, 2011

    Report

    Report Number
    1723170-2011-01162
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PART HAS BEEN RETURNED. RMA ISSUED FOR REPLACEMENT MOUSE TO BE SENT TO SITE.

    Description of Event or Problem · 1

    A NEURO COORDINATOR REPORTED THE MOUSE USED WITH A S7 SYSTEM STOPPED WORKING TOWARDS THE END OF A NEURO CASE. NO IMPACT ON THE PT OUTCOME WAS REPORTED.

    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 55 YR