BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3843255 · Received June 2, 2014

    Report

    Report Number
    1723170-2014-00534
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 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

    RMA ISSUED. REPLACEMENT VERTEK ARM II SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT THE RETURNED VERTEK ARM WAS IN GOOD CONDITION AND FUNCTIONED NORMALLY. THE ARM PASSED THE FORCE TEST WITHOUT ISSUE. NO PROBLEM FOUND. DEVICE FOUND TO BE FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    CORRECTION: UPON REVIEW OF THIS REPORT IT WAS FOUND THAT THE MDR-1723170-2014-00534 WAS SUBMITTED IN ERROR AND WAS A DUPLICATE OF MDR-1723170-2014-00325 FOLLOWUP #1.THE CORRECT DEVICE EVALUATION IS AS FOLLOWS: A MEDTRONIC REPRESENTATIVE CLARIFIED THAT THE DEVICE FROM THIS REPORT WAS NOT REPLACED AS PREVIOUSLY REPORTED. SHE CHECKED OUT THE ARM AND IT WAS WORKING FINE. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE MOST LIKELY CAUSE WAS USER TECHNIQUE OF NOT PROPERLY TIGHTENING THE DEVICE. THE REP HAD THE SITE PUT THE DEVICE IN THE INSTRUMENT TRAY THAT IS RARELY USED AND THE SITE WILL CONTINUE TO USE THE NEW ONE FROM A PREVIOUS REPLACEMENT (SEE MDR-1723170-2014-00325 FOLLOWUP #1) FOR NON-STERILE REGISTRATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL TUMOR RESECTION THE VERTEK ARM BECAME LOOSENED AT THE LOWER ELBOW JOINT. THE SURGEON SUCCESSFULLY REGISTERED THE PATIENT, WENT STERILE, BEGAN NAVIGATION, THEN ALLEGED A 3-4CM INACCURACY. THE SURGEON OPTED TO DISCONTINUE THE USE OF THE NAVIGATION SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321290 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR