BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CHAMBER TEMPORARY PACEMAKER

    MDR report key: 8861570 · Received August 5, 2019

    Report

    Report Number
    3004593495-2019-00790
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 8, 2019
    Report Date
    September 26, 2019
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    DTE
    PMA / PMN Number
    K150246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD DAMAGED OUTPUT CONNECTORS. IT WAS RECOMMENDED THAT THE EPG BE RETURNED FOR SERVICE, BUT ITS CURRENT STATUS IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE EPG WAS RETURNED FOR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655348 DUAL CHAMBER TEMPORARY PACEMAKER PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE PLEXUS MANUFACTURING SDN. BHD 5392

    Patients

    Seq Age Sex Outcome Treatment
    1