BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4250095 · Received November 7, 2014

    Report

    Report Number
    3008642652-2014-03710
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    September 26, 2014
    Report Date
    November 5, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) IS COMPLETE. THE MONITOR WAS FULLY FUNCTIONAL UPON RECEIPT. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) IS COMPLETE. THE BELT WAS FULLY FUNCTIONAL UPON RECEIPT. REVIEW OF THE PT'S ECG STRIPS AND FLAG FILES DOES NOT INDICATE A DEVICE MALFUNCTION DURING USE. THERE IS NO REASON TO SUGGEST THE LIFEVEST DEVICE CAUSE OR CONTRIBUTED TO THE PT'S DEATH. THROUGH REVIEW OF THE PT'S DOWNLOADED DATA FILE AND EVALUATION OF EQUIPMENT UPON RECEIPT, THERE IS NO INDICATION THAT THE LIFEVEST DEVICE CAUSE OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    A U.S. DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT PASSED AWAY ON (B)(6) 2014. THE PT WAS AT HOME AT THE TIME OF DEATH. PRIOR TO PASSING, THE PT RECEIVED SEVEN TREATMENT SHOCKS ON (B)(6) 2014 AT 16:35:15, 16:35:40, 16:36:06, 16:36:33, 16:48:37, 16:49:03, 16:48:37, 16:49:03, AND 16:57:09 IN RESPONSE TO ASYSTOLE. OVER-SENSING OF SMALL CARDIAC ACTIVITY CONTRIBUTED TO THE FALSE DETECTION. THE PT'S WIFE FOUND THE PT DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718515 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death