BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K162309

    MDR report key: 9322632 · Received November 14, 2019

    Report

    Report Number
    1723170-2019-05618
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 29, 2019
    Report Date
    January 29, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    PGW
    UDI-DI
    00643169838918
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SOFTWARE ANALYSIS WAS INITIATED. HOWEVER, THE SOFTWARE EVALUATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735736, VERSION #: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. UPON INITIAL CHECKOUT, A COMPUTER BOOT-UP ISSUE WAS EXPERIENCED. IT WAS FOUND THE SSD WAS CAUSING A "NO VIDEO INPUT." THEN UPON A SECOND CHECKOUT, THE INITIAL REPORTED ISSUE COULD NOT BE CONFIRMED OR REPLICATED, NO COMPONENTS WERE REPLACED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED THE AMOUNT OF INACCURACY WAS APPROXIMATELY 3MM. THE ISSUE RESULTED IN A 5-10 MINUTE PROCEDURE DELAY.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. DURING THE PROCEDURE, THE SITE HAD DIFFICULTY REGISTERING THE PATIENT. WHEN TRACE REGISTRATION WAS PERFORMED, THE MODEL REPORTEDLY KEPT FLIPPING UPSIDE DOWN. THE SITE ADDED TOUCH POINTS AND THE ISSUE RESOLVED. LATER IN THE PROCEDURE, A SLIGHT NAVIGATION INACCURACY WAS EXPERIENCED. THE PROCEDURE WAS COMPLETED AND THE SURGEON ACCOUNTED FOR THE INACCURACY. THE LENGTH OR PROCEDURE DELAY WAS UNKNOWN. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117486 K162309 INSTRUMENT, STEREOTAXIC PGW MEDTRONIC NAVIGATION, INC 9735669 00643169838918

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR