BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CHAMBER TEMPORARY PACEMAKER

    MDR report key: 8903110 · Received August 16, 2019

    Report

    Report Number
    3004593495-2019-00836
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 21, 2019
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    DTE
    PMA / PMN Number
    K150246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS NOTED THAT THE EXTERNAL PULSE GENERATOR (EPG) FAILED INCOMING FUNCTIONAL TESTS FOR THE DISPLAY BACK LIGHT. A CAPACITOR WAS BROKEN OFF THE MAIN PRINTED CIRCUIT BOARD (PCB). ANALYSIS ALSO NOTED THAT THE UPPER CASE WAS BROKEN. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE DEVICE PASSED ALL FINAL FUNCTIONAL TESTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WAS RETURNED TO THE COMPANY SERVICE DEPARTMENT FOR REGULAR PREVENTATIVE MAINTENANCE AND 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
    694819 DUAL CHAMBER TEMPORARY PACEMAKER PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE PLEXUS MANUFACTURING SDN. BHD 5392

    Patients

    Seq Age Sex Outcome Treatment
    1