BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4240892 · Received November 10, 2014

    Report

    Report Number
    1723170-2014-01204
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOW PROVIDED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT MADE AVAILABLE FROM THE SITE. (B)(6) 2014, A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. REPORTED ISSUE COULD NOT BE REPLICATED. (B)(6) 2014, A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE TISSUE/TUMOR BIOPSY WAS INCONCLUSIVE. THERE WAS A 4-5 MINUTE DELAY AT THE TIME OF THE PROCEDURE. SOFTWARE INVESTIGATION COMPLETED; FINDINGS ARE THAT THE CORRECT TRACER PATTERN WAS NOT FOLLOWED. SOFTWARE IS FUNCTIONING AS DESIGNED; ISSUE DETERMINED TO BE THE RESULT OF A USE ERROR.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL BIOPSY PROCEDURE, THE SURGEON ALLEGED A 5MM INACCURACY. NO FURTHER DETAILS WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721885 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR