BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 SYSTEM

    MDR report key: 19886910 · Received August 1, 2024

    Report

    Report Number
    1723170-2024-01925
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    May 15, 2024
    Report Date
    August 1, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735737, VERSION #: 2.1.0. H3) SOFTWARE ANALYSIS WAS PERFORMED AND DID NOT CONFIRM THE REPORTED ISSUE. THE RESULTS OF THE SOFTWARE ANALYSIS CONCLUDED THAT NO SOFTWARE FAILURE WAS FOUND. THE LOGS HAD TWO SESSIONS ON THE DATE OF ISSUE AND IN SESSION 1 REFERENCE OID: (B)(4). CT-1 WITH THIS EXAM AS REFERENCE ALL THE REGISTRATIONS WERE PERFORMED. THEN THE REFERENCE EXAM CHANGED TO REFERENCE OID: (B)(4) WHICH IS MR-2. SO, NOW THAT THE REFERENCE EXAM WAS CHANGED THE REGISTRATION DATA WOULD BE LOST. AFTER WHICH THERE WAS NO REGISTRATION PERFORMED AND THE REFERENCE EXAM WAS CHANGED BACK TO COMPUTED TOMOGRAPHY (CT) CT-1. IN THE SECOND SESSION AS WELL THERE WAS CHANGE IN THE REFERENCE EXAMS CONTINUOUSLY. FROM THIS INFORMATION IT WAS EVIDENT THAT CHANGE IN THE REFERENCE EXAM CAUSED THE REGISTRATION DATA TO BE LOST WHICH WAS EXPECTED. CODES: B01, C19, D14. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SITE WAS MISSING THEIR PREVIOUS REGISTRATION AFTER MERGING IN AN EXTRA MAGNETIC RESONANCE IMAGING (MRI) SCAN. THE SITE HAD ORIGINALLY REGISTERED THE PATIENT, PERFORMED THEIR TUMOR RESECTION, TAKEN AN INTRAOPERATIVE MAGNETIC RESONANCE IMAGING (IMRI) TO CHECK THEIR PROGRESS, AND DECIDED TO GO BACK TO RESECT MORE OF THE TUMOR. AFTER MERGING IN THE MRI, THEY WERE UNABLE TO FIND THEIR PREVIOUS REGISTRATION. THEY ENDED UP REREGISTERING THE PATIENT TO CONTINUE WITH SURGERY. THE MANUFACTURER REPRESENTATIVE (REP) CHECKED THAT THE ORIGINAL SCAN THE PREVIOUS REGISTRATION WAS BASED ON, WAS STILL MERGED IN THE PATIENT. CHECKED TO MAKE SURE IT WAS STILL IN THE SAME OPTICAL VS EMITTER PROCEDURE TYPE. TRIED UNMERGING SCANS AND LOOKING FOR PREVIOUS REGISTRATIONS UNDER ORIGINAL SCAN USED. THERE WAS A 10-15 MINUTE DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217222 STEALTHSTATION¿ S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO Female "SEE H11...."