BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1667339 · Received April 19, 2010

    Report

    Report Number
    3002158293-2010-00383
    Event Type
    Death
    Date Received
    April 19, 2010
    Date of Event
    January 28, 2010
    Report Date
    April 19, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE: MONITOR (B) (4): 09/2008; ELECTRODE BELT (B) (4): 01/2009. DEVICE EVAL SUMMARY: DEVICE EVALS ON MONITOR (B) (4) AND ELECTRODE BELT (B) (4) HAVE BEEN COMPLETED. BOTH THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL UPON RECEIPT AND WERE ABLE TO PERFORM A BASELINE AND PT TREATMENT SEQUENCE. THE PT LIKELY PASSED ON (B) (6) 2010. DURING THE TIME THE LIFEVEST DEVICE WAS MONITORING THIS PT, NO TREATABLE ARRHYTHMIAS WERE DETECTED. THE SYSTEM'S BATTERY WAS PULLED DURING AN EPISODE AND BRADYCARDIA, PREVENTING FURTHER MONITORING OF THE PT'S DETERIORATING CONDITION. THE DATE IS INCONCLUSIVE ON CAUSE OF DEATH. HOWEVER, NUMEROUS BRADYCARDIA FLAGS WERE RECORDED IN THE FLAG FILES. THERE IS NO EVIDENCE TO INDICATE THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PT'S DEATH.

    Description of Event or Problem · 1

    THE ACCOUNT COORDINATOR (AC) OF A (B) (6) MALE PT EMAILED ZOLL LIFECOR CUSTOMER SUPPORT TO INFORM OF THE PT'S PASSING. THE AC REPORTED THAT THE PT WAS WEARING THE LIFEVEST AND PASSED ON ARRIVAL AT THE HOSPITAL IN THE COMPANY OF THE PARAMEDICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death