BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 20470525 · Received October 17, 2024

    Report

    Report Number
    1723170-2024-03173
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    October 11, 2024
    Report Date
    October 17, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000359881
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID 9735797, H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD BEEN EXPERIENCING WIRELESS COMMUNICATION ISSUES SINCE LAST YEAR AFTER THE HOSPITAL CHANGED THEIR ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS) NETWORK. WHEN THEY TRY TO DOWNLOAD PATIENT EXAMS WIRELESSLY, THE DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) ASSOCIATION BETWEEN PACS AND NAVIGATION UNITS INTERMITTENTLY TIME OUT AND ONLY QUERY A FEW IMAGES AT A TIME, RATHER THAN DOWNLOADING THE FULL EXAM AT ONCE. THE SYSTEM WOULD RETRIEVE ABOUT 10 IMAGES AT A TIME AND CONTINUE TO MAKE SEPARATE QUERIES UNTIL ALL IMAGES HAVE BEEN DOWNLOADED. EACH TIME THE SITE TRIED TO DOWNLOAD AN EXAM, IT SEEMS LIKE MULTIPLE ASSOCIATIONS WERE CREATED, AND EACH ASSOCIATION PULLS A SUBSET OF IMAGES OF THE EXAM. IF YOU WERE TO ADD ALL THE SCANS PULLED, IT ADDED UP TO THE TOTAL NUMBER OF SLICES IN THE ONE EXAM. WITH THEIR NEW PACS SYSTEM (INTELERAD/INTELEPACS) THE NEW NETWORK WAS DESIGNED WITH AN IP RANGE THAT DIFFERS BETWEEN EACH FLOOR OF THE HOSPITAL. THE SITE HAD LESS INTERMITTENT ISSUES USING 2.4GHZ THAN 5GHZ, BUT ISSUE HAS NOT FULLY RESO LVED. IT WAS CONFIRMED THAT USING A WIRED ETHERNET CONNECTION SUCCESSFULLY DOWNLOADS ALL IMAGES AT ONCE WITH NO INTERRUPTION OR DIFFICULTY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203400 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000359881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...