BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 9290197 · Received November 7, 2019

    Report

    Report Number
    1723170-2019-05500
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 26, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID:930556, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN; PRODUCT ID:960556, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN. THE PRODUCT ID FOR THE PASSIVE PLANAR PROBE WAS REPORTED AS UNKNOWN. BOTH 930556 AND 960556 WERE PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM WAS PERFORMING AS INTENDED. THE SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SITE WAS ABLE TO USE THE PASSIVE PLANAR BLUNT PROBE ENOUGH TO SEE WHAT THEY WANTED TO SEE. THE SITE WAS HAVING TROUBLE GETTING THE PROBE TO TRACK WHEN TRYING TO NAVIGATE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL BIOPSY. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE PASSIVE PLANAR BLUNT WAS FLICKERING BETWEEN RED AND GREEN IN THE SOFTWARE. A MANUFACTURER REPRESENTATIVE HAD THE SITE REPLACE THE SPHERES AND THOUGHT IT RESOLVED THE ISSUE, BUT IT OCCURRED LATER IN THE CASE. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION SYSTEM AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084653 STEALTHSTATION S7 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR