BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3771477 · Received April 24, 2014

    Report

    Report Number
    1723170-2014-00414
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PER FURTHER REVIEW, THE REPORTED EVENT DID NOT MEET THE DEFINITION OF SERIOUS INJURY AS NO INJURY OCCURRED WHICH REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE. THEREFORE, THE EVENT WAS CORRECTED FROM ADVERSE EVENT SELECTED ON THE INITIAL 3500A TO PRODUCT PROBLEM ON THIS FOLLOW UP REPORT. DEVICE EVALUATION: TWO COMPONENTS OF THE NAVIGATION SYSTEM (CD/DVD DRIVE AND COMPUTER) WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CD/DVD DRIVE TRANSFERRED EXAMS PROPERLY DURING TESTING. THE COMPUTER BOOTED TO LOG-IN AND PASSED ALL TESTING WITH NO PROBLEM FOUND. BOTH COMPONENTS WERE FOUND TO BE FULLY FUNCTIONAL. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS NOT BEEN PROVIDED. A MEDTRONIC REPRESENTATIVE, FOLLOWING UP WITH THE SITE, REPORTED THAT THE SURGERY WAS RESCHEDULED AND COMPLETED ON (B)(6) 2014. RMA ISSUED AND A REPLACEMENT COMPUTER WAS SHIPPED TO THE SITE ON (B)(6) 2014. ON (B)(6) 2014 - A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, AND FOUND THAT THE PATIENT EXAMS WILL NOT LOAD VIA CD AFTER COMPUTER REPLACEMENT. SHE NOTICED THAT THERE WAS DAMAGE TO THE COMMUNICATION CABLE TO THE DRIVE. SHE ALSO SAID THAT SHE HEARD RATTLING IN THE REPLACEMENT COMPUTER THAT WAS SENT TO HER. REQUESTED A REPLACEMENT COMPUTER AND CD DRIVE. RMA ISSUED AND ANOTHER REPLACEMENT COMPUTER WAS SHIPPED TO THE SITE ON (B)(6) 2014. ON (B)(6) 2014, A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, AND ALL AREAS PASSED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE NAVIGATION SYSTEM WOULD NOT POWER ON. THE SITE REPRESENTATIVE CHECKED THE EXTERNAL MONITOR CONNECTIONS, PULLED OFF THE BACK PANEL RE-SEATED THE COMPUTER POWER CABLE HOWEVER THAT DID NOT RESOLVE THE ISSUE. THE SURGEON OPTED TO HALT THE PROCEDURE AND RESCHEDULE IT. THE PATIENT WAS UNDER ANESTHESIA FOR 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249286 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R