BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC SURGICAL NAVIGATION SYSTEM S7

    MDR report key: 5955797 · Received September 14, 2016

    Report

    Report Number
    MW5064795
    Event Type
    Other
    Date Received
    September 14, 2016
    Date of Event
    July 27, 2016
    Report Date
    September 14, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    HAW
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS MEDTRONIC, SURGICAL NAVIGATION SYSTEM WAS TO BE USED FOR THE PLACEMENT OF A VENTRICULAR SHUNT. TWO DIFFERENT PATIENT TRACKING DEVICES WERE USED, BOTH MEDTRONIC PRODUCTS, ITEM #9734887 AND #9733674. WHEN THE SECOND PATIENT TRACKER WAS CONNECTED INTO THE NAVIGATION SYSTEM, A WARNING PROMPT APPEARED ON THE COMPUTER SCREEN, ASKING IF THE USER IF HE WANTED TO REGISTER THE TRACKER. THE USER ANSWERED "YES" AND THIS RESULTED IN ALL OF THE DATA FROM THE FIRST TRACKER TO BE DELETED FROM THE SYSTEM. THE DATA WAS IRRETRIEVABLE AND PROCEDURE WAS COMPLETED WITHOUT THE USE OF THE NAVIGATION SYSTEM. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601379 MEDTRONIC SURGICAL NAVIGATION SYSTEM S7 MEDTRONIC SURGICAL NAVIGATION SYSTEM S7 HAW MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR 9733674| TRACKER: 9734887