BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5026443 · Received August 24, 2015

    Report

    Report Number
    3008642652-2015-05170
    Event Type
    Death
    Date Received
    August 24, 2015
    Date of Event
    July 19, 2015
    Report Date
    August 24, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. THE PATIENT PASSED AWAY ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT ENDED USE OF THE LIFEVEST PRIOR TO PASSING. DEVICE EVALUATION WAS ACCOMPLISHED THROUGH A REVIEW OF THE PATIENT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE DEFIBRILLATION EVENT. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 07/19/2011 - REUSE; ELECTRODE BELT SN (B)(4): 08/09/2012 - REUSE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT WAS TREATED AND PASSED AWAY ON (B)(6) 2015 IN THE HOSPITAL. THE LIFEVEST DETECTED VENTRICULAR TACHYCARDIA AT 17:12:30. THE LIFEVEST DELIVERED ONE APPROPRIATE TREATMENT AT 17:13:39. THE RHYTHM AT THE TIME OF TREATMENT WAS VT. THE PATIENT RECEIVED A SECOND TREATMENT WHICH WAS INAPPROPRIATE AT 17:14:02. THE RHYTHM AT THE TIME OF THE INAPPROPRIATE TREATMENT WAS SINUS BRADYCARDIA. THE POST SHOCK RHYTHM WAS SINUS BRADYCARDIA. MULTIPLE COUNTING OF TALL TWAVES CONTRIBUTED TO THE FALSE DETECTION. A REVIEW OF THE DOWNLOADED DATA INDICATES THAT THE RESPONSE BUTTONS WERE PRESSED DURING THE EVENT BUT NOT DURING THE TREATMENT SEQUENCE THAT RESULTED IN THE DEFIBRILLATION SHOCK. IT WAS REPORTED THAT THE PATIENT ENDED USE OF THE LIFEVEST BEFORE THE TIME OF DEATH. THE PATIENT PASSED AWAY ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559089 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| O