BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 6160221 · Received December 9, 2016

    Report

    Report Number
    3004593495-2016-00482
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 29, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: MANUFACTURER'S ANALYSIS INDICATED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A BROKEN OUTPUT CONNECTOR ASSEMBLY. IT WAS ALSO INDICATED THAT THE EPG HAD A CONTAMINATED HANGER ASSEMBLY. THESE PARTS WERE REPLACED AND THE EPG PASSED FINAL FUNCTIONAL AND SYSTEM TESTS. 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.

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR (EPG) WAS RETURNED FOR FIELD ACTION SERVICE 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
    814296 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE PLEXUS MANUFACTURING SDN. BHD 5392

    Patients

    Seq Age Sex Outcome Treatment
    1