BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4649041 · Received March 25, 2015

    Report

    Report Number
    3008642652-2015-01306
    Event Type
    Death
    Date Received
    March 25, 2015
    Date of Event
    April 29, 2014
    Report Date
    March 12, 2015
    Manufacturer
    ZOLL MANUFACTURING CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) WAS COMPLETED. AS RECEIVED, THE MONITOR WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. ELECTRODE BELT SN (B)(4) WAS NOT RETURNED FOR INVESTIGATION. DEVICE MFG DATE: MONITOR (B)(4): 09/2012. ELECTRODE BELT (B)(4): 04/01/2013.

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST TREATMENT EVENTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. A ZOLL TERRITORY MANAGER CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) FEMALE PT WAS TREATED BY THE LIFEVEST AND PASSED AWAY. THE LIFEVEST TREATED THE PT AT 17:30:07 ON (B)(6) 2014. THE RHYTHM AT THE TIME OF THE TREATMENT WAS ASYSTOLE WITH SEVERE BRADYCARDIA (8 BPM). THE POST-SHOCK RHYTHM WAS IDIOVENTRICULAR (88 BPM) WHICH DEGRADED TO ASYSTOLE. THE DEVICE WAS SHUTDOWN AT 17:35:49. EMS WAS ON THE SCENE AND TRANSPORTED THE PT TO THE HOSPITAL WHERE THE PT PASSED AWAY. OVERSENSING OF SMALL CARDIAC SIGNAL AND SIGNAL ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THERE IS NO INDICATION THAT THE TREATMENT DURING ASYSTOLE CONTRIBUTED TO THE PT'S DEATH. ASYSTOLE IS CONSIDERED A NON-TREATABLE RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199989 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| O