BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3920297 · Received July 8, 2014

    Report

    Report Number
    1723170-2014-00734
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DECLINED TO PROVIDE PATIENT INFORMATION, REFERENCING (B)(4) PRIVACY LAWS. RMA ISSUED. REPLACEMENT HEADFRAME ADAPTER SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT HEADFRAME ADAPTER FINDS THAT THIS PART IS PER SPECIFICATIONS AND FUNCTIONS NORMALLY. NO PROBLEM FOUND. DID NOT CAUSE EVENT. NO FURTHER ISSUES REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE THE NAVIGATION SYSTEM HEADFRAME ATTACHMENT WAS FASTENED FIRMLY BUT WAS EASILY MOVED WITH TENSION ON THE SUPPORT ARM. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397662 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1