BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9733856 S7 STAFF ASSEMBLED 110V

    MDR report key: 8710108 · Received June 18, 2019

    Report

    Report Number
    1723170-2019-03552
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    April 2, 2018
    Report Date
    June 18, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: SOFTWARE 9735585 STEALTH STATION CRANIAL, UPN (B)(4), 510K K153660. THE SOFTWARE INVESTIGATION WAS UNABLE 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 DURING AN ELECTRODE AND PROBE PLACEMENT SURGERY. IT WAS REPORTED THAT WHEN THE SITE WAS ATTEMPTING TO MEASURE THE DISTANCE BETWEEN TWO TARGET POINTS, THEY WERE UNABLE TO MEASURE BECAUSE THEY WOULD KEEP SELECTING THE TARGET THEY DID NOT WANT TO SELECT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE AND NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500551 CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR