BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT, STEREOTAXIC

    MDR report key: 8643268 · Received May 26, 2019

    Report

    Report Number
    1723170-2019-02657
    Event Type
    Malfunction
    Date Received
    May 26, 2019
    Date of Event
    August 29, 2017
    Report Date
    May 26, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169504394
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SYSTEM 9733320 AXIEM INTEGRATED 4 PORT (SERIAL #: (B)(4)) FOUND NO FAULT, AS THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE RETURNED AXIEM APPEARS TO BE NEW AND THE LOT NUMBER MATCHES THE LABEL ON THE BOX, BUT THE AXIEM HAD BEEN REMOVED FROM THE PACKAGE, LIKELY FOR TROUBLESHOOTING PURPOSES. THE AXIEM WAS CONNECTED TO A TEST SYSTEM FOR A MULTI-HOUR BURN-IN TEST. THE SYSTEM REMAINED IN GREEN STATUS DURING ALL TESTING. REGISTRATION, TRACKING, AND ACCURACY LOOKED NORMAL ON ALL 4 TOOL PORTS. THE TOOLS FROM EACH PORT WERE CONNECTED/DISCONNECTED MULTIPLE TIMES AND THE SYSTEM REMAINED FUNCTIONAL. NO PROBLEM FOUND. ANALYSIS OF THE PCA 9733600 I/O HUB ENCLOSED (LOT #: 170328) FOUND NO FAULT, AS THE RETURNED I/O HUB APPEARED TO BE NEW AND THE LOT NUMBER MATCHES THE LABEL ON THE BOX, BUT THE HUB HAD BEEN REMOVED FROM THE PACKAGE, LIKELY FOR TROUBLESHOOTING PURPOSES. IN ADDITION, THE HUB WAS FOUND TO BE FULLY FUNCTIONAL HAVING PASSED THE I/O HUB TEST PER (B)(4) WITH NO FAILURES. NO PROBLEM FOUND. ANALYSIS OF THE CABLE 9733597 EXTERNAL AXIEM PWR/DATA (LOT #: 161228) FOUND NO FAULT, AS THE RETURNED CABLE APPEARED TO BE NEW AND THE LOT NUMBER LABEL MATCHES THE PACKAGE LABEL. HOWEVER, THE CABLE HAS BEEN REMOVED FROM THE PACKAGE, LIKELY FOR TROUBLESHOOTING PURPOSES. OTHERWISE, THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. NO PROBLEM FOUND. ANALYSIS OF THE FIELD GENERATOR 9731203 EM MOBILE (LOT #: 0400008195) FOUND NO FAULT, AS THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE RETURNED FIELD GENERATOR APPEARED TO BE NEW AND THE LOT NUMBER MATCHES THE LABEL ON THE BOX, BUT THE FIELD GENERATOR HAS BEEN REMOVED FROM THE PACKAGE, LIKELY FOR TROUBLESHOOTING PURPOSES. THE FIELD GENERATOR WAS CONNECTED TO A TEST SYSTEM FOR A MULTI-HOUR BURN-IN TEST. THE SYSTEM REMAINED IN GREEN STATUS DURING ALL TESTING. FLEXING THE CABLE DOES NOT INDICATE ANY INTERMITTENT OPENS. NO PROBLEM FOUND. PRODUCT EVENT SUMMARY #AXIEM COMMS ISSUE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9731203, SERIAL/LOT #: (B)(4), UDI#: (B)(4); PRODUCT ID: 9733597, SERIAL/LOT #: (B)(4); PRODUCT ID: 9733600, SERIAL/LOT #: (B)(4); PRODUCT ID: 9733320, SERIAL/LOT #: (B)(4), UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE AXIEM WILL NOT COMMUNICATE. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436638 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560 00643169504394

    Patients

    Seq Age Sex Outcome Treatment
    1