BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2439205 · Received January 31, 2012

    Report

    Report Number
    3008642652-2012-00328
    Event Type
    Death
    Date Received
    January 31, 2012
    Date of Event
    January 7, 2012
    Report Date
    January 30, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION, IT WAS DISCOVERED THAT ONE OF THE REAR THERAPY ELECTRODES DID NOT DEPLOY GEL DURING THE TREATMENT EVENT. THE CAUSE FOR THE BELT FAILING TO DEPLOY GEL WAS A BROKEN GEL FIRE WIRE IN THE REAR THERAPY ELECTRODE INTERCONNECT. THE ROOT CAUSE FOR THE BROKEN WIRE COULD NOT BE POSITIVELY IDENTIFIED. THE OTHER TWO THERAPY ELECTRODES SUCCESSFULLY DEPLOYED GEL. THE IMPEDANCE DURING THE TREATMENTS FELL WITHIN THE NORMAL RANGE (48 TO 60 OHMS). THERE IS NO EVIDENCE TO SUGGEST THAT THE G EL FIRE FAILURE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE MONITOR FAILED A DRIVEN GROUND RELAY TEST DUE TO AN OPEN RESISTOR R781. THE ROOT CAUSE FOR THE OPEN CONNECTION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO EXTERNAL DEFIBRILLATION BY THE PARAMEDICS. THE DAMAGED DRIVEN GROUND RELAY DID NOT AFFECT PATIENT PROTECTION, AS THE DEVICE WAS PROPERLY MONITORING THE PATIENT'S RHYTHM IN THE FIELD. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4) MANUFACTURED 10/2010. ELECTRODE BELT SN (B)(4) MANUFACTURED 06/2010.

    Description of Event or Problem · 1

    A ZOLL ACCOUNT COORDINATOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) OLD FEMALE PATIENT HAD PASSED AWAY AFTER BEING TREATED BY THE LIFEVEST. THE PATIENT WAS TREATED 12 TIMES WHILE AT HOME. ACCORDING TO THE PATIENT'S HUSBAND, THE DEVICE ALARMED TO CALL 911. PARAMEDICS ARRIVED AND REMOVED THE LIFEVEST AND INITIATED THEIR OWN TREATMENTS. THE PATIENT WAS NON-RESPONSIVE, AND WAS LATER PRONOUNCED DEAD AT THE HOSPITAL. THE PATIENT RECEIVED FIVE TREATMENTS BETWEEN 3:33:12 AND 3:40:25 ON (B)(6) 2012 WHILE EXPERIENCING VENTRICULAR TACHYCARDIA. THESE INITIAL FIVE TREATMENTS SUCCESSFULLY CONVERTED THE ARRHYTHMIAS TO SLOWER RHYTHMS. VENTRICULAR FIBRILLATION RESUMED 23 SECONDS AFTER THE FIFTH TREATMENT. A SIXTH TREATMENT WAS ADMINISTERED AT 3:40:59 AND WAS UNABLE TO CONVERT THE RHYTHM. VF CONTINUED, AND A SEVENTH TREATMENT WAS ADMINISTERED AT 3:41. THE POST-SHOCK RHYTHM WAS SVT AT 118 BPM. ANOTHER ARRHYTHMIA (VF) WAS DECLARED AT 3:41:44. THE PATIENT RECEIVED FIVE CONSECUTIVE TREATMENTS AT 3:42:28, 3:42:59, 3:43:37, 3:44:04, AND 3:44:47. THESE TREATMENTS WERE UNABLE TO CONVERT THE PATIENT'S ARRHYTHMIA. AFTER DELIVERING FIVE CONSECUTIVE TREATMENTS WITHOUT CONVERTING THE ARRHYTHMIA, THE LIFEVEST ALARMED TO CALL 911, AS THE DEVICE IS DESIGNED TO DO. PARAMEDICS ARRIVED AND SHUTDOWN THE DEVICE AT 3:46:43. AS REPORTED BY THE PATIENT'S HUSBAND, THE PARAMEDICS ALSO DEFIBRILLATED THE PATIENT EN ROUTE TO THE HOSPITAL. THE PATIENT PASSED AWAY SHORTLY AFTER ARRIVING AT THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death