BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3895157 · Received June 25, 2014

    Report

    Report Number
    1723170-2014-00680
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    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 PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT VERTEK ARM SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT THE VERTEK ARM WAS VERY WORN WITH NICKS AND SCRATCHES OVER THE ENTIRE SURFACE OF THE INSTRUMENT. AS REPORTED, THE ARM WILL NOT LOCK DOWN COMPLETELY. MECHANICAL FAILURE, MALFUNCTION - WILL NOT TIGHTEN, DIRECTLY CAUSED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A SITE VERTEK ARM THAT WOULD NOT LOCK PROPERLY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372144 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1