BEUDAMED
    FDA Adverse Event Death Summary report: N

    USA ELITE IGLESIAS W. ELEMENT

    MDR report key: 1053923 · Received May 22, 2008

    Report

    Report Number
    1519132-2008-00007
    Event Type
    Death
    Date Received
    May 22, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 21, 2008
    Manufacturer
    GYRUS ACMI, INC.- NORWALK
    Product Code
    FDC
    PMA / PMN Number
    K951972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON OUR EVAL, GYRUS ACMI CANNOT FIND ANY FUNCTIONAL PROBLEM WITH THIS WORKING ELEMENT. ALL FUNCTIONAL CHECKS PASSED. HOWEVER, WE HAVE NOT BEEN PROVIDED WITH THE ELECTRODE OR THE GENERATOR THAT WAS USED IN THIS PROCEDURE, AND THUS, WE CANNOT COMMENT ON THE FUNCTIONING OF THE ENERGY-GENERATING COMPONENTS. ABSENT THE AVAILABILITY OF THIS EQUIPMENT, WE CANNOT ESTABLISH A CASUAL CONNECTION BETWEEN THE USAGE OF THE SUBJECT DEVICE AND THE REPORTED PT DEATH. SHOULD THESE BECOME AVAILABLE, GYRUS ACMI WILL REOPEN ITS INVESTIGATION OF THIS EVENT AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    THIS EVENT WAS INITIALLY REPORTED TO GYRUS ACMI AS A REPAIR REQUEST, AND AT THE TIME OF THE INITIAL REPORTING, NO INFO WAS PROVIDED REGARDING ANY PT INVOLVEMENT. ON MAY 16, 2008 GYRUS ACMI WAS INFORMED BY THE FACILITY THAT THE DEVICE WAS USED DURING A PROCEDURE, SUBSEQUENT TO WHICH A PT DEATH WAS REPORTED. SINCE IT IS NOT CLEAR WHAT RELATIONSHIP THE SUBJECT DEVICE MAY HAVE HAD TO THE REPORTED DEATH, IF ANY, GYRUS ACMI IS PROVIDING THIS REPORT TO THE AGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE IGLESIAS W. ELEMENT WORKING ELEMENT FDC GYRUS ACMI, INC.- NORWALK EIWE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death