BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3180577 · Received June 20, 2013

    Report

    Report Number
    1723170-2013-00451
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT AVAILABLE FROM THE SITE. THIS WAS REPORTED TO THE MANUFACTURER VIA MEDWATCH# (B)(4) ON (B)(6) 2013. DATE OF THE INCIDENT LISTED ON THE MEDWATCH FORM WAS (B)(6) 2013. THESE FIELDS WERE COMPLETED ON MEDWATCH# (B)(4) ALTHOUGH THE COMPONENT REPORTED "NAVIGATION ARM" IS A REUSABLE DEVICE. A MEDTRONIC REP WENT TO THE SITE TO COLLECT THE SUSPECT COMPONENT. HOWEVER, THE SITE REP REFUSED TO RELINQUISH THE DEVICE PER INSTRUCTION FROM THE SITE'S LEGAL DEPARTMENT. IT WAS REPORTED TO THE MEDTRONIC REP THAT THE SITE HAD SENT THE DEVICE TO A 3RD PARTY VENDOR FOR REPAIR PRIOR TO THE REPORTED EVENT. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED VIA MEDWATCH# (B)(4) THAT A PATIENT WAS SCHEDULED FOR A RIGHT FRONTAL LESION BIOPSY WITH THE USE OF A INTRAOPERATIVE NAVIGATION SYSTEM. THE NAVIGATION ARM, WHICH IS ATTACHED TO THE REFERENCE FRAME, BECAME LOOSE AND SHIFTED SLIGHTLY. THE SLIGHT SHIFT CAUSED THE NAVIGATION PATH TO BE OFF, AND AS A RESULT HEALTHY TISSUE WAS BIOPSIED. ONCE A FUNCTIONING ARM WAS IDENTIFIED A 2ND BIOPSY WAS PERFORMED DURING THE SAME SURGERY AND THE CASE WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2013, A MEDTRONIC REP AT THE SITE WAS INFORMED, WHILE GATHERING PATIENT DEMOGRAPHICS, THAT THE PATIENT WAS DECEASED. THE OR MANAGER AT THE SITE INFORMED THE MEDTRONIC REP THAT THERE WAS NO ALLEGATION THAT THE PATIENT'S DEATH WAS RELATED TO THE BIOPSY INCIDENT. THE OR MANAGER SAID THAT SHE DID NOT FEEL THE SURGERY WAS RELATED TO DEATH BECAUSE THE PATIENT WAS ALREADY VERY SICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280336 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR