BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3843785 · Received May 23, 2014

    Report

    Report Number
    3008642652-2014-01574
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZOLL LIFECORD 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 OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WAS COMPLETED. UPON RECEIPT THE ELECTRODE BELT WAS FULLY FUNCTIONAL. UPON RECEIPT THE MONITOR FAILED INCOMING TESTING. THE CAUSE FOR THE TEST FAILURE WAS AN OPEN RESISTOR, R781. THE R781 RESISTOR WAS LIKELY DAMAGED DURING THE PHYSICIAN'S ATTEMPTS TO RESUSCITATE THE PT WITH AN EXTERNAL DEFIBRILLATION. WHILE IN USE, THE DEVICE FUNCTIONED AS DESIGNED. THE LIFEVEST DETECTED VENTRICULAR TACHYCARDIA (VT) (AT 272BPM) AT 03:56:16 ON (B)(6) 2014. PRIOR TO THE FIRST 150J SHOCK AT 3:56:50 THE RHYTHM SELF CONVERTED TO SUPER VENTRICULAR TACHYCARDIA (SVT). THE POST-SHOCK RHYTHM WAS A SINUS RHYTHM AT 83 BPM WITH FREQUENT PREMATURE VENTRICULAR CONTRACTIONS (PVCS). THE LIFEVEST DETECTED VT AT 264 BPM AT 3:59:40 AND DELIVERED A 117J SHOCK AT 4:00:11. THE POST-SHOCK RHYTHM WAS VENTRICULAR FIBRILLATION (VF) WITH MOTION ARTIFACT. THE PT RECEIVED TWO ADDITIONAL 150J SHOCKS BY THE LIFE VEST DURING EPISODES OF VF AT 4:00:36 AND 4:01:10. IN BOTH CASES THE POST-SHOCK RHYTHM WAS VF. AFTER THE TREATMENTS DELIVERED BY THE LIFEVEST, THE DEVICE RECORDED TWO EXTERNAL SHOCKS DURING TWO EPISODES OF VF. THE SECOND EXTERNAL DEFIBRILLATION RESULTED IN ASYSTOLE. A REVIEW OF THE PT DATA REVEALED LOW AMPLITUDE ON THE FRONT TO BACK LEAD AND HIGH IMPEDANCE (610 OHMS) AT THE TIME OF THE SECOND SHOCK INDICATING A POSSIBILITY OF POOR CONTACT BETWEEN THE ELECTRODES AND THE PT WHICH IS THE LIKELY CAUSE FOR THE LOW ENERGY SHOCK. THERE IS NO EVIDENCE THAT THE MONITOR WAS UNABLE TO DETECT AND TREAT DURING THE EVENT. THE MONITOR DELIVERED TWO 150J SHOCKS AFTER THE 117J SHOCK. THERE WERE NO ALLEGED DEFICIENCIES AGAINST THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, ZOLL CUSTOMER SUPPORT WAS NOTIFIED THAT A (B)(6) YEAR OLD MALE PT PASSED AWAY WHILE IN THE HOSPITAL. NO DEFICIENCIES WERE ALLEGED. AFTER INITIALLY REVIEWING THIS EVENT, ZOLL DETERMINED THAT THE EVENT WAS NOT REPORTABLE. ON (B)(6) 2014, ZOLL CUSTOMER SUPPORT REPORTED THAT A DOWNLOAD SHOWED THE PT WAS TREATED FOUR TIMES BY THE LIFEVEST AND WAS EXTERNALLY DEFIBRILLATED TWICE WHILE WEARING THE LIFEVEST ON (B)(6) 2014. AFTER REVIEWING THIS DATA, ZOLL DECIDED TO REPORT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307974 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECORD CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death