BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9733856 S7 STAFF ASSEMBLED 110V

    MDR report key: 8676985 · Received June 6, 2019

    Report

    Report Number
    1723170-2019-03039
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    March 1, 2018
    Report Date
    June 6, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: SOFTWARE 9735585 STEALTH STATION CRANIAL; UDI: (B)(4); 510K/PMA: K153660. THE SYSTEM EXAMS WERE RECEIVED FOR ANALYSIS. THE SITE WAS USING CT AS A REFERENCE WHEN SWITCHING FROM T1 TO T2, WHICH WAS WHEN THE ACPC CHANGED. IT WAS NOT POSSIBLE TO REPLICATE THE REPORTED ISSUE. THE SOFTWARE INVESTIGATION FOUND THAT IT WAS NOT POSSIBLE TO DETERMINE PROBABLE CAUSE WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHILE DOING TRACTS THE AC/PC WAS STORED AND MERGED WITH A T1 AND T2. WHEN LOOKING AT THE TWO, THE AC/PC APPEARED FINE, BUT ON THE HYBRID EXAM IT SHIFTED LEFT 1-2 MM. THE MERGE LOOKED LIKE IT LINED UP WHEN THE MERGE WAS VERIFIED. THE SITE WAS USING CT AS A REFERENCE AND T1 AND T2 EXAMS. UPON RE-EXAMINATION OF THE EXAMS, IT WAS POSSIBLE TO SEE SHIFTING FOR THE POINTS. WHEN LOOKING AT THE EXAM MERGE, THE EXAMS WERE SLIGHTLY SHIFTING. THE THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468125 CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1