BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1140074 · Received August 29, 2008

    Report

    Report Number
    3002158293-2008-00422
    Event Type
    Death
    Date Received
    August 29, 2008
    Date of Event
    July 12, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFG DATE: MONITOR - 04/2008, ELECTRODE BELT - 07/2007. BATTERY PACK - 12/2007. BATTERY PACK - 09/2007. DEVICE EVALUATION: ALL THE EQUIPMENT WAS FULLY FUNCTIONAL. IT WAS REFURBISHED, RETESTED AND RESTOCKED. FROM THE FLAGS IT CAN BE SEEN THAT THE BATTERY PACK WAS PULLED FROM THE DEVICE PRIOR TO THE PATIENT'S DEATH. THE PATIENT WAS WEARING THE SYSTEM WITHOUT IT BEING POWERED UP.

    Description of Event or Problem · 1

    IN 2008, A LIFECOR PATIENT SERVICES REPRESENTATIVE (PSR) CALLED LIFECOR CUSTOMER SUPPORT TO REPORT THAT A MALE PATIENT HAD DIED OVER THE WEEKEND. SUPPORT HAD THE PSR DOWNLOAD THE DEVICE AND THE DOWNLOAD REVEALED THAT THE PATIENT WAS NOT WEARING THE DEVICE AT THE TIME OF DEATH. SUPPORT CONTACTED THE PSR ON 7/28/2008 FOR MORE INFORMATION. SHE STATED THAT THE PATIENT WAS WEARING THE DEVICE AT TIME OF DEATH ACCORDING TO THE HOSPITAL PERSONNEL.

    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 66 YR Death