BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CHAMBER TEMPORARY PACEMAKER

    MDR report key: 11817782 · Received May 13, 2021

    Report

    Report Number
    2182208-2021-01927
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 12, 2021
    Report Date
    August 18, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    UDI-DI
    00763000162443
    PMA / PMN Number
    K150246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL EVALUATION WAS CARRIED OUT, THE MAIN BOARD WAS ASSEMBLED INTO A GOLDEN UNIT. THE DEVICE POWERED UP WITHOUT PROBLEM. THE BACKLIGHT, VENTRICULAR, AND ATRIAL OUTPUT PACING FUNCTIONED PROPERLY, HOWEVER, THE DEVICE POWERED DOWN IMMEDIATELY AFTER BATTERY REJECTED. IT WAS IDENTIFIED THAT THE BATTERY SUPPLY WAS WITHIN THE SPECIFICATION REQUIREMENTS, BUT THE SUPPER CAP CHARGE VOLTAGE SC-V 0 VOLT FAILED TO MEET THE SPECIFICATION. FOUND C39 CAPACITOR LEAKAGE DUE TO CONTAMINATION. REPLACING C39 CAPACITOR RESTORED SC-V CHARGE VOLTAGE. THE DEVICE WAS POWERED UP THE DEVICE FOR 10 MINUTES, THEN REJECTED THE BATTERY THE DEVICE POWERED DOWN AFTER 3 MINUTES. 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

    PRODUCT ANALYSIS: ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER COMMENT THAT ERROR OCCURRED MULTIPLE TIMES. IT WAS NOTED THAT THE MAIN PRINTED CIRCUIT BOARD (PCB), UPPER CASE, ENCODER ASSEMBLY, FOUR KNOBS, LOWER CASE, LIQUID CRYSTAL DISPLAY (LCD), DISPLAY FRAME, INSULATOR LABEL, TWO CASE SCREWS AND FOUR ENCODER NUTS WERE ALL CONTAMINATED AND THE HANGER ASSEMBLY WAS BROKEN. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE DEVICE THEN PASSED ALL FINAL FUNCTIONAL TESTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WHICH WAS RECEIVED INTO SERVICE FOR REPAIR SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719434 DUAL CHAMBER TEMPORARY PACEMAKER PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE MEDTRONIC, INC. 5392 00763000162443

    Patients

    Seq Age Sex Outcome Treatment
    1