BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT SUCTION, AXIEM

    MDR report key: 2981036 · Received February 27, 2013

    Report

    Report Number
    1723170-2012-00697
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PROVIDED CORRECT LOT NUMBER AND DEVICE MANUFACTURER DATE.

    Additional Manufacturer Narrative · 1

    THE MEDTRONIC REPRESENTATIVE WAS INFORMED THAT INSTRUMENTS SHOULD BE REPLACED IF THEY WILL NOT CONSISTENTLY VERIFY, AND THAT THEY SHOULD NOT BE MANIPULATED IN ORDER TO PASS VERIFICATION.

    Additional Manufacturer Narrative · 1

    NO PT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. D4: DEVICE LOT NUMBER IS UNAVAILABLE AT TIME OF THIS REPORT. THE DEVICE MANUFACTURE DATE IS UNKNOWN PENDING THE DEVICE RETURN. SUSPECT PART HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED ADJUSTING THE STRAIGHT SUCTION, AXIEM IN ORDER TO OBTAIN PROPER CALIBRATION. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84086 STRAIGHT SUCTION, AXIEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 60355100

    Patients

    Seq Age Sex Outcome Treatment
    1