BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2980795 · Received February 15, 2013

    Report

    Report Number
    3008642652-2013-00493
    Event Type
    Death
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PT DEATH) HAS BEEN INVESTIGATED. UPON RECEIPT THE ELECTRODE BELT WAS FOUND TO BE FULLY FUNCTIONAL. DEVICE EVAL OF MONITOR SN (B)(4) HAS NOT YET BEEN COMPLETED. DUE TO THE LACK OF A DATA DOWNLOAD FROM THE MONITOR, THE INVESTIGATION INTO THE PT DEATH IS STILL UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF DEVICE EVAL AND DEATH INVESTIGATION. MONITOR SN (B)(4) MFR DATE: 03/2011, ELECTRODE BELT SN (B)(4) MFR DATE: 12/2010.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT WAS NOTIFIED OF A PT DEATH VIA AN EMAIL FROM ZOLL BILLING. PER ZOLL BILLING, THE PT'S FAMILY REPORTED THAT THE PT WAS WEARING THE DEVICE AT THE TIME OF DEATH. THE PT'S FAMILY ALSO REPORTED THAT THE DEVICE DID NOT ALARM AND THAT IT WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69558 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death