BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 6005601 · Received October 6, 2016

    Report

    Report Number
    3004593495-2016-00396
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    August 22, 2016
    Report Date
    August 22, 2016
    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
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION NOTED BUT RETURNED PRODUCT INVESTIGATION FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. THE DEVICE IS NO LONGER INCLUDED AS PART OF THE FIELD ACTION. PRODUCT EVENT SUMMARY: MANUFACTURER¿S ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE OUTPUT CONNECTOR ASSEMBLY WAS BROKEN AND THAT TWO KNOBS WERE MISSING FROM THE DEVICE. IT WAS ALSO NOTED THAT THE HANGER ASSEMBLY OF THE DEVICE, ALONG WITH ONE CASE SCREW, WERE CONTAMINATED. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A BROKEN VENTRICULAR OUTPUT AND WAS MISSING TWO KNOBS. THE EXTERNAL PULSE GENE RATOR HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655634 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE PLEXUS MANUFACTURING SDN. BHD 5392

    Patients

    Seq Age Sex Outcome Treatment
    1