BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2834272 · Received November 15, 2012

    Report

    Report Number
    1723170-2012-00636
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS PROVIDED AS NO PATIENT WAS PRESENT. THE SITE STATED THEY HAVE ALREADY PURCHASED A REPLACEMENT VERTEK ARM THROUGH MEDTRONIC CUSTOMER SERVICE AND STATED THAT THE OLDER, DAMAGED VERTEK ARM WILL NOT BE RETURNED TO THE MANUFACTURER FOR THE EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SITE HAD BROKEN THEIR VERTEX ARM AND IT WILL NOT TIGHTEN DOWN PROPERLY. THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM, NO PATIENT WAS PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1