BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 4301582 · Received November 28, 2014

    Report

    Report Number
    3008642652-2014-04254
    Event Type
    Death
    Date Received
    November 28, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 18, 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) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PT DEATH) WAS INVESTIGATED. AS RECEIVED, THE MONITOR WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. ELECTRODE BELT SN (B)(4) HAS NOT YET BEEN RETURNED. REVIEW OF THE PT'S DOWNLOADED DATA INDICATES THAT THE ELECTRODE BELT WAS FULLY FUNCTIONAL WHILE IN USE. THERE IS NO INDICATION TO SUGGEST THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PT'S DEATH. MONITOR (B)(4): 04/2012; ELECTRODE BELT (B)(4): 07/2008.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL ON (B)(6) 2014 TO REPORT THAT A PT PASSED AWAY AT HOME WHILE WEARING THE LIFEVEST. ON 11/10/2014, ZOLL WAS NOTIFIED THAT THE PT EXPERIENCED TWO INAPPROPRIATE DEFIBRILLATIONS DURING ASYSTOLE. REVIEW OF THE EVENT CONCLUDES THAT THE PT RECEIVED TWO INAPPROPRIATE SHOCKS DURING ASYSTOLE. OVERSENSING OF SMALL CARDIAC SIGNAL CONTRIBUTED TOT HE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT AS THE PT WAS UNCONSCIOUS. THE PT PASSED AWAY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771658 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIB MVK ZOLL MANUFACTURING CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death