BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1614468 · Received February 19, 2010

    Report

    Report Number
    3002158293-2010-00172
    Event Type
    Death
    Date Received
    February 19, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 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

    MFR DATE: MONITOR (B) (4): 02/2008, ELECTRODE BELT (B) (4): 12/2006. DEVICE EVAL SUMMARY: DEVICE EVALUATIONS OF ELECTRODE BELT (B) (4) AND MONITOR (B) (4) HAVE BEEN COMPLETED. THE DEVICE WAS FULLY FUNCTIONAL UPON RECEIPT. IT WAS REFURBISHED AND RETESTED. FROM THE FLAGS, IT CAN BE SEEN THAT THE DEVICE PROPERLY TREATED THE PT DURING AN EPISODE OF VENTRICULAR TACHYCARDIA, HOWEVER, THE POST-SHOCK RHYTHM WAS ASYSTOLE. THIS IS A RARE COMPLICATION OF CARDIOVERSION. THE DEVICE THEN PROPERLY DETECTED AND ALARMED FOR ASYSTOLE. THE EVENT ANALYSIS, ALONG WITH THE PT'S ECG REPORT, IS ATTACHED. CONCLUSION: A (B) (6) WOMAN REC'D AN APPROPRIATE SHOCK DURING AN EPISODE OF VT. THE PT'S POST-SHOCK RHYTHM WAS ASYSTOLE, A RARE COMPLICATION OF CARDIOVERSION. THE DEVICE THEN PROPERLY DETECTED AND ALARMED FOR ASYSTOLE, ATTRACTING HER MOTHER'S ATTENTION. .

    Description of Event or Problem · 1

    THE TERRITORY MGR (TM) OF A (B) (6) FEMALE PT CALLED IN TO ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PT HAD PASSED AWAY WHILE WEARING THE LIFEVEST. THE PT'S DEVICE WAS ALARMING "CALL AMBULANCE." REVIEW OF THE PT'S DOWNLOAD REVEALED THAT THE PT PASSED AWAY ON (B) (6) 2010.

    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 25 YR Death