BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT SUCTION, AXIEM¿

    MDR report key: 3173594 · Received June 17, 2013

    Report

    Report Number
    1723170-2013-00441
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DEVICE MANUFACTURING DATE IS UNAVAILABLE AT THIS TIME. SUSPECT DEVICE HAS NOT YET BEEN RETURNED TO MANUFACTURER FOR EVALUATION; RETURN IS NOT ANTICIPATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT IN A SUBSEQUENT CASE THE INSTRUMENT DID NAVIGATE AFTER ITS THIRD TRY WITH NO FAULTS. THE REP ATTENDED 7 CASES AT THE FACILITY, AND HAS NOT SEEN THE ISSUE COME UP AGAIN WITH ANY OF THEIR INSTRUMENT SETS. THE REP SAW EACH SET USED AND ALL OF THEIR INSTRUMENTS WERE FULLY FUNCTIONAL. THE REP IS MONITORING THE ISSUE AT THE SITE AND WILL REMOVE ANY SUSPECT INSTRUMENTS IF THERE IS A RECURRENCE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN AN ENT PROCEDURE, THEY WERE UNABLE TO VERIFY A STRAIGHT SUCTION. THE DEVICE VERIFIED AT THE START OF THE SURGERY, HOWEVER, THEY WERE UNABLE TO RE-VERIFY LATER. ALL OTHER INSTRUMENTS WORKED WITHOUT ISSUE. 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
    273093 STRAIGHT SUCTION, AXIEM¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 71191700

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR