BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4748827 · Received May 1, 2015

    Report

    Report Number
    3008642652-2015-02633
    Event Type
    Death
    Date Received
    May 1, 2015
    Date of Event
    December 11, 2013
    Report Date
    April 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY. DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. THERE WAS NO DEVICE MALFUNCTION. DEVICE MANUFACTURE DATE. MONITOR: REUSE; ELECTRODE BELT: 04/2012 - REUSE.

    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. ZOLL CUSTOMER SUPPORT WAS NOTIFIED VIA DEVICE DOWNLOAD DATA THAT A (B)(6) YR OLD MALE PATIENT WAS TREATED 12 TIMES ON (B)(6) 2013. THE PATIENT WAS IN HOSPICE CARE AT THE TIME OF THE EVENT. THE LIFEVEST DELIVERED A TREATMENT AT 02:56:29 DURING ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RESPONSE (163 BPM). A SECOND TREATMENT WAS DELIVERED AT 02:57:11 DURING NSVT. NINE MORE TREATMENTS WERE DELIVERED BETWEEN 03:43:19 AND 04:17:16. FOLLOWING THE 11TH TREATMENT, THE PATIENT'S RHYTHM DEGRADED TO BRADYCARDIA AND ASYSTOLE. A 12TH TREATMENT WAS DELIVERED AT 05:45:19 DURING ASYSTOLE WITH IRREGULAR ATRIAL ACTIVITY. THE FINAL POST-SHOCK RHYTHM WAS SEVERE BRADYCARDIA TRANSITIONING TO ASYSTOLE. THE PATIENT SUBSEQUENTLY PASSED AWAY. RAPID ATRIAL FIBRILLATION AND OVERSENSING OF CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTIONS. THE RESPONSE BUTTONS WERE NOT USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289327 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death