BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1252223 · Received December 3, 2008

    Report

    Report Number
    3002158293-2008-00618
    Event Type
    Death
    Date Received
    December 3, 2008
    Date of Event
    November 9, 2008
    Report Date
    December 2, 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 SUMMARY: SEE ATTACHED ECG RECORDING OF THE EVENT.

    Description of Event or Problem · 1

    THE WIFE OF PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT HER HUSBAND HAD PASSED AWAY. SHE STATED THAT THE SYSTEM ALARMED, AND BY THE TIME SHE GOT TO HIM, HE WAS DEAD. SHE CALLED THE PARAMEDICS, AND THEY REMOVED THE DEVICE WHEN THEY GOT THERE. THE ELECTRODE BELT WAS LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death