BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2081104 · Received April 14, 2011

    Report

    Report Number
    1723170-2011-00785
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 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

    RMA ISSUED. EMITTER REPLACED. DEVICE EVALUATION FOUND THAT THE SYSTEM DISPLAYED "ERROR EMITTER LOW DRIVE CURRENT." IN DIAGNOSTIC, SHOWED LOW DRIVE CURRENT FAULT ON ONE OF THE LINE ON AMP BOARD B. THIS INDICATES AN OPEN TO THE EMITTER COIL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE RECEIVES AN INTERMITTENT ERROR CONCERNING THE AC POWER WHEN USING THE AXIEM WITH THE STEALTHSTATION S7 SYSTEM. WHEN THEY DISCONNECT AND RE-CONNECT THE POWER PART OF THE CABLE TO THE AXIEM BOX THEY CAN SUCCESSFULLY RE-ESTABLISH COMMUNICATION AND THE SYSTEM WORKS PROPERLY. THERE WAS NO PATIENT PRESENT.

    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 NONE