BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1163049 · Received September 16, 2008

    Report

    Report Number
    3002158293-2008-00444
    Event Type
    Death
    Date Received
    September 16, 2008
    Date of Event
    July 27, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE DEVICE HAS NOT BEEN RETURNED TO LIFECOR. IF THE DEVICE IS RECOVERED A SUPPLEMENTAL REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THE WIFE OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT HAD PASSED AWAY. THE PT WAS WEARING THE DEVICE AT THE HOSP BEFORE BEING DISCHARGED. THE STAFF STATED THAT THE PT WENT INTO THE ELECTROMECHANICAL DISSOCIATION AND TOLD THE WIFE THAT THERE WAS NOTHING THE DEVICE COULD HAVE DONE. THE EQUIPMENT WAS MISPLACED/LOST. THE HOSPITAL STATES THAT THE FAMILY SIGNED FOR THE BELONGINGS AND THE FAMILY STATES THEY DO NOT HAVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death