BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKULL-MOUNT PATIENT TRACKER

    MDR report key: 5025583 · Received August 24, 2015

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    Report

    Report Number
    1723170-2015-01018
    Event Type
    Malfunction
    Date Received
    August 24, 2015
    Date of Event
    July 27, 2015
    Report Date
    September 22, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K141833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER FIELD NOT SUFFICIENT TO HOLD ALL DIGITS, SHOULD READ: (B)(6). DEVICE MANUFACTURING DATE IS UNAVAILABLE. A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE SITE COULD NOT GET THE SCREWS TO WORK WITH THE PATIENT'S SKULL, IT WAS SUSPECTED THAT THE PATIENT'S BONE WAS TOO THIN AND THE SCREWS WERE NOT ABLE TO MAKE APPROPRIATE CONTACT. THE SITE TRIED TWO DIFFERENT DYNAMIC REFERENCE FRAMES (DRF) BUT WERE UNSUCCESSFUL. THE SURGEON PROCEEDED WITH THE SURGERY USING THE REGULAR REFERENCE FRAME. DRF FRAMES WERE DISPOSED OF SO THEY WILL NOT BE RETURNED FOR INVESTIGATION NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. SUSPECT PART WAS DISCARDED BY THE SITE AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE WAS UNAVAILABLE AS A VALID LOT NUMBER WAS NOT PROVIDED AND THE DEVICE WAS DISCARDED.(B)(4)

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, THE DYNAMIC REFERENCE FRAME (DRF) WAS NOT ABLE TO MOUNT PROPERLY TO THE PATIENT. NO FURTHER DETAILS REGARDING THE CONCERN, OR WHEN IN THE PROCEDURE IT OCCURRED, 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
    559411 SKULL-MOUNT PATIENT TRACKER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) T022

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR