BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 EM ENT

    MDR report key: 10200602 · Received June 26, 2020

    Report

    Report Number
    1723170-2020-01775
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    June 23, 2020
    Report Date
    July 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
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION: LOT NUMBER OF PRODUCT ID: 9735765 IS 191015. H3) AN ADDITIONAL SYSTEM CHECKOUT WAS PERFORMED AND FOUND THAT HARDWARE PARTS WERE REPLACED. A SYSTEM CHECKOUT WAS SUCCESSFULLY PERFORMED. A POWER CABLE WAS RETURNED TO THE MANUFACTURER, HOWEVER, IT WAS NOTED THAT IT WAS UNUSED. FOLLOW-UP IS BEING CONDUCTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735765, SERIAL/LOT #: UNKNOWN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE REPORTED ISSUE WAS CONFIRMED. THE POWER CABLE TO THE MONITOR WAS CAUSING THE MONITOR TO WORK INTERMITTENTLY. THE CABLE WAS NOT INDICATED TO BE REPLACED AT THE TIME OF FILING. 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 BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT DURING SYSTEM INSTALLATION, THE SYSTEM HAD A DAMAGED MONITOR POWER CABLE CAUSING THE MONITOR TO INTERMITTENTLY SHUT ON AND OFF. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667368 STEALTHSTATION S8 EM ENT INSTRUMENT, STEREOTAXIC PGW MEDTRONIC NAVIGATION, INC 9735669 00643169838918

    Patients

    Seq Age Sex Outcome Treatment
    1