BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAME 9733886 SMALL ACTIVE HC

    MDR report key: 8661246 · Received June 1, 2019

    Report

    Report Number
    1723170-2019-02835
    Event Type
    Malfunction
    Date Received
    June 1, 2019
    Date of Event
    July 20, 2017
    Report Date
    June 1, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169545601
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE FRAME 9733886 SMALL ACTIVE HC (LOT #: 160309) FOUND A DAMAGED TOOL. WHEN CONNECTED TO A KNOWN GOOD SYSTEM, IT WAS FOUND THAT LEDS #2 AND #4 WERE NOT FIRING. PRODUCT EVENT SUMMARY: #MATTERS S7 RECOGNITION FAILURE OF LED REFERENCE FRAME PRODUCT ANALYSIS: (B)(4): MNAV FINDINGS AND CONCLUSIONS: WHEN CONNECTED TO A KNOWN GOOD SYSTEM IT WAS FOUND THAT LEDS #2 AND #4 WERE NOT FIRING. MNAV METHODOLOGY: FUNCTIONAL TESTING;VISUAL/PHYSICAL EXAMINATION. MNAV USABILITY: FALSE. MNAV ABLE TO DUPLICATE THE ISSUE?: YES. MNAV BAI/OOBF?: FALSE. MNAV FAILURE MODE: ELECTRICAL. MNAV FAILURE MECHANISM: MALFUNCTION, LED. 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 SYSTEM EVENT HAVING OCCURRED INTRA-OPERATIVELY OF A PROCEDURE. IT WAS REPORTED THAT THE LED SMALL ACTIVE REFERENCE FRAME HAD A RECOGNITION FAILURE DURING THE CASE. IT WAS STATED THEY WERE ABLE TO COMPLETE THE CASE WITH NAVIGATION. NO FURTHER INFORMATION REGARDING THE PROCEDURE PROVIDED. NO REPORTED IMPACT TO PATIENT AND LESS THAN AN HOUR OF DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454630 FRAME 9733886 SMALL ACTIVE HC INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733886 160309 00643169545601

    Patients

    Seq Age Sex Outcome Treatment
    1