BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2681230 · Received July 31, 2012

    Report

    Report Number
    3008642652-2012-01888
    Event Type
    Death
    Date Received
    July 31, 2012
    Date of Event
    May 21, 2012
    Report Date
    July 31, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT TREATED, PATIENT DEATH) HAS BEEN INVESTIGATED. UPON INVESTIGATION THE CABLE CONNECTING THE DISTRIBUTION NODE TO THE REAR THERAPY ELECTRODE WAS RIPPED. THE ROOT CAUSE FOR THE DAMAGED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. THE DAMAGE MAY HAVE OCCURRED AS THE LV WAS BEING REMOVED FROM THE PT AFTER THE APPROPRIATE TREATMENT, ALTHOUGH, WE HAVE NO EVIDENCE OF THIS IN OUR CALL REPORT. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT TREATED, PATIENT DEATH) HAS BEEN INVESTIGATED. AS RECEIVED, THE MONITOR EXPERIENCED A DRIVEN GROUND FAILURE DURING THE FULL MONITOR TEST. UPON INVESTIGATION, IT WAS DISCOVERED THAT RESISTOR R781 ON THE MONITOR CA BOARD WAS OPEN, CAUSING A FAILURE OF THE MONITOR'S DRIVEN GROUND CIRCUITRY. THE ROOT CAUSE OF THE DAMAGE DRIVEN GROUND CIRCUITRY CANNOT BE POSITIVELY IDENTIFIED; HOWEVER, THE OPEN R781 IS CONSISTENT WITH DAMAGE THAT OCCURS WHEN A PT RECEIVES EXTERNAL RESCUE DEFIBRILLATION, ALTHOUGH, WE HAVE NO EVIDENCE OF THIS OCCURRENCE. DEVICE MANUFACTURE DATE: SN (B)(4): 04/2012. SN (B)(4): 12/2010. TREATMENT AND DEATH ANALYSIS CONCLUSION: A (B)(6)MALE RECEIVED ONE APPROPRIATE SHOCK DURING ONE EPISODE OF VENTRICULAR TACHYCARDIA WITHIN A SINGLE 24-HOUR PERIOD. THE ARRHYTHMIA WAS SUCCESSFULLY CONVERTED TO A SLOWER RHYTHM BY ONE 150 JOULE SHOCK. HOWEVER, THE RHYTHM THEN TRANSITIONED INTO ASYSTOLE. THE PT PASSED AWAY ON (B)(6) 2012. THE DEVICE PROPERLY DETECTED AND ALARMED FOR ASYSTOLE AND BRADYCARDIA. NO TREATMENT SEQUENCE WAS INITIATED FOR ASYSTOLE OR BRADYCARDIA, AS THESE ARE CONSIDERED NON SHOCKABLE RHYTHMS. THE DEVICE PROPERLY DETECTED AND TREATED THE VENTRICULAR ARRHYTHMIA.

    Description of Event or Problem · 1

    A ZOLL BILLING EMPLOYEE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT HAD PASSED AWAY. AN ANALYSIS OF THE TREATMENT EVENT, PERFORMED BY ZOLL, REVEALED THAT THE PT RECEIVED 1 APPROPRIATE SHOCK FOR VENTRICULAR TACHYCARDIA (VT) AT 237 BEATS PER MINUTE WHICH CONVERTED THE VT TO A SLOWER ORGANIZED RHYTHM AT 30 BEATS PER MINUTE. PT'S HEART RATE CONTINUED TO SLOW AND ASYSTOLE WAS DECLARED APPROX 2 MINUTES LATER. PT SUBSEQUENTLY PASSED AWAY.

    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 72 YR Death