BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHNAVIGATOR ENAV SYSTEM

    MDR report key: 3932414 · Received July 14, 2014

    Report

    Report Number
    1723170-2014-00750
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, NEW INFORMATION WAS RECEIVED (SEE B5) WHICH CLARIFIED THE REPORTED EVENT AS UNLIKELY TO CAUSE SERIOUS HARM. IF THIS INFORMATION WAS AVAILABLE DURING THE INITIAL REVIEW THE REPORTED EVENT WOULD NOT HAVE BEEN CONSIDERED A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, NEW INFORMATION WAS RECEIVED FROM THE EVALUATION OF THE RETURNED DEVICE WHICH CONTRADICTED THE REPORTED EVENT ON THE PREVIOUSLY SUBMITTED 3500A FOLLOW-UP 1. THE REPORTED EVENT WAS REVERSED BACK TO A REPORTABLE MALFUNCTION BASED ON THE FOLLOWING JUSTIFICATION: ALTHOUGH NO PATIENT PRESENT, THE ALLEGED MALFUNCTION MAY NOT BE NOTICED DURING SETUP HAVING THE POTENTIAL TO CAUSE HARM IF THE INSTRUMENT WAS USED DURING SURGERY AND THE ALLEGED MALFUNCTION WERE TO CAUSE FRAME MOVEMENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND SHOWED SIGNS OF PHYSICAL DAMAGE. THE REFERENCE FRAME ARM WOULD NOT LOCK DOWN WHEN THE HANDLE WAS TIGHTENED. ALSO, THE HANDLE HAD BEEN BROKEN OFF. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A NAVIGATION SYSTEM VERTEK ARM THAT COULD NOT BE FIXED PROPERLY. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THIS ISSUE WAS DETECTED DURING TRAINING AND THERE WAS NO PATIENT PRESENT.

    Description of Event or Problem · 1

    ON (B)(6), 2014, A MEDTRONIC REPRESENTATIVE REPORTED THAT THE REFERENCE FRAME ARM WAS JAMMED AND COULDN'T BE LOOSENED. IT HAPPENED DURING A TRAINING, SO NO PATIENT WAS INVOLVED. WE JUST USED ANOTHER ARM IN THAT PARTICULAR MOMENT, THERE WAS NO IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410699 STEALTHNAVIGATOR ENAV SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. ENAV

    Patients

    Seq Age Sex Outcome Treatment
    1