BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4524868 · Received February 13, 2015

    Report

    Report Number
    3008642652-2015-00691
    Event Type
    Death
    Date Received
    February 13, 2015
    Date of Event
    December 22, 2014
    Report Date
    February 11, 2015
    Manufacturer
    ZOLL MANUFACTURING CORP
    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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B)(4) IS COMPLETE. AS RECEIVED, THE ELECTRODE BELT WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION, THE R781 COMPONENT ON THE MONITOR CA BOARD WAS OPEN CAUSING A LOSS OF DRIVEN GROUND SIGNAL. THIS COMPONENT FAILURE IS CONSISTENT WITH DAMAGE SEEN WHEN THERE IS AN EXTERNAL RESCUE DEFIBRILLATION. THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE FAILURE CAUSED OR CONTRIBUTED TO THE PT DEATH. MONITOR (B)(4): 03/2014 - REUSE, ELECTRODE BELT (B)(4): 03/2010 - REUSE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE PT DEATH. THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PT'S DEATH.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A (B)(6) MALE PT PASSED AWAY ON (B)(6) 2014 IN THE HOSPITAL ICU. AT 18:15:05, THE LIFEVEST DETECTED BRADYCARDIA AT 30 BPM TRANSITIONING TO VENTRICULAR TACHYCARDIA (VT) AT 160 BPM WITH MOTION ARTIFACT. BETWEEN 18:15:20 AND 18:20:20, THE PT RECEIVED SEVEN NON-LIFEVEST EXTERNAL DEFIBRILLATION SHOCKS. DURING THIS TIME, THE PT'S RHYTHM CONVERTED ONLY BRIEFLY AFTER THE TREATMENTS BEFORE THE VT/VF REOCCURRED. THE LIFEVEST SHUTDOWN AT 18:29:22 ON (B)(6) 2014 WHILE THE PT WAS IN VF. THE VT/VF WAS NOT DETECTED BY THE LIFEVEST BECAUSE THE ARRHYTHMIA RATE WAS BELOW THE THRESHOLD FOR DETECTION. THE DEVICE THRESHOLD SETTING WERE 200 BPM FOR BOTH VT AND VF. DURING THIS TIME, MOTION ARTIFACT WAS SEEN ON THE ECGS. THERE WERE NO ALLEGED DEFICIENCIES AGAINST THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107307 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death