BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 PREMIUM

    MDR report key: 9627328 · Received January 24, 2020

    Report

    Report Number
    1723170-2020-00230
    Event Type
    Malfunction
    Date Received
    January 24, 2020
    Date of Event
    January 6, 2020
    Report Date
    April 3, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION: LOT NUMBER OF PRODUCT ID: 9735821 IS P901761. THE POSITIONING SENSOR UNIT (PSU) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE PSU POWERED UP ON THE TEST BENCH WITHOUT THE AMBER FAULT LIGHT ON. A CHECK OF THE EVENT LOG SHOWED INSTANCES OF FIRMWARE INCOMPATIBILITY AND THE STORAGE TEMPERATURE EXCEEDED. THE PSU ALSO FAILED AN ACCURACY TEST. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO AN ELECTRICAL ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. 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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. THE UNIQUE IDENTIFIER WAS NOT AVAILABLE AT THE TIME OF REPORTING. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821, SERIAL/LOT #: UNKNOWN. INITIAL REPORTER WAS NOT KNOWN AT THE TIME OF REPORTING. REPORT SOURCE FOREIGN COUNTRY: (B)(6). THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. THE REPORTED ISSUE WAS NOT CONFIRMED AND IS STILL UNDER INVESTIGATION AT THE TIME. THE MANUFACTURE DATE WAS NOT AVAILABLE AT THE TIME OF REPORTING. 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. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT AFTER BRINGING IN THE CLINICAL TRIAL DEVICE D9 ITEM OF NAVIGATION SYSTEM WHICH WAS A MEDTRONIC FIXED ASSET, THE POSITIONING SENSOR UNIT (PSU) ERROR LED LIT UP DURING OPERATION CHECK. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91908 S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1