BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 4832310 · Received June 10, 2015

    Report

    Report Number
    3004593495-2015-00097
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 30, 2015
    Report Date
    March 30, 2015
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    DTE
    PMA / PMN Number
    K150246
    Removal / Correction Number
    Z-1356-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THREE SELF-TEST STUCK BUTTONS (ON/OFF) DETECTED IN THE DEVICE LOG AND THREE RECOVERED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE OUTPUT CONNECTOR NUT WAS MISSING. IT WAS ALSO NOTED THAT THE DISPLAY WIRE INSULATION WAS PINCHED BUT THE WIRE INSULATION WAS NOT COMPROMISED, ONE CASE SCREW WAS CONTAMINATED, AND THE MAIN SEAL WAS PINCHED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE CONNECTOR ISSUES WITH THE EPG (EXTERNAL PULSE GENERATOR). THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE CONNECTOR ISSUES WITH THE EPG (EXTERNAL PULSE GENERATOR). THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE NUT FOR THE ATRIAL CONNECTOR CAME OFF. THE CONNECTOR FELL INSIDE THE EPG, AND THE MAIN SEAL GASKET WAS HANGING OUT A HALF INCH AT THE BOTTOM OF THE DEVICE NEAR THE BATTERY DRAWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380047 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE PLEXUS MANUFACTURING SDN. BHD 5392

    Patients

    Seq Age Sex Outcome Treatment
    1