BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATION STEALTH STATION S7 SYSTEM

    MDR report key: 8970710 · Received September 6, 2019

    Report

    Report Number
    1723170-2019-04784
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 12, 2019
    Report Date
    November 22, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS ON THE RETURNED COMPUTER RESULTED IN NO FAILURE BEING FOUND THROUGH FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION. ANALYSIS STATES THAT THE COMPUTER BOOTS NORMALLY AND INSTALLED APPLICATIONS STARTS AND RUNS NORMALLY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS ADDED TO THE EVENT DESCRIPTION. THE SOFTWARE ANALYSIS WAS COMPLETED AND THE REPORTED ISSUE COULD NOT BE CONFIRMED BECAUSE THE REPORTED ISSUE COULD NOT BE REPLICATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT SEX NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT COMPUTER REPLACEMENT WAS NEEDED. THE MANUFACTURING REPRESENTATIVE REPLACED THE COMPUTER AND THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. THE COMPUTER WAS RETURN TO MEDTRONIC, HOWEVER, ANALYSIS HAS NOT BEEN COMPLETED. DEVICE MANUFACTURING DATE IS UNAVAILABLE. OTHER RELEVANT DEVICE(S) ARE: COMPUTER 9735225 ROLLINGSTONE S7 / LOT #: 1832515. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO IMPACT TO THE PATIENT. THEY WERE TESTING TWO MACHINES AT ONCE TO SEE WHICH ONE HAD THE PROBLEM. THEY USED THE OTHER MACHINE FOR THE CASE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE SITE BECAME INACCURATE IN THE MIDDLE OF THE CASE. THEY REGISTERED AND WAS ACCURATE. THEY COULD NOT CONFIRM IF THE TRACKER HAD MOVED, HOWEVER, THEY DO GO STERILE AFTER REGISTERING. THE SITE USED ANOTHER SYSTEM, REGISTERED, AND KEPT ACCURACY. THEY SWAPPED OUT THE EM BOX AND EMITTERS WITH A GOOD SYSTEM AND THE INACCURACY WAS STILL BEING EXPERIENCED. THERE WAS A LESS THAN 1-HOUR DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762563 NAVIGATION STEALTH STATION S7 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR