BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4956589 · Received July 31, 2015

    Report

    Report Number
    3008642652-2015-04782
    Event Type
    Death
    Date Received
    July 31, 2015
    Date of Event
    June 29, 2015
    Report Date
    November 13, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE MONITOR WAS FOUND TO BE FULLY FUNCTIONAL AND ABLE TO DETECT AN ARRHYTHMIA AND DELIVER A TREATMENT DEFIBRILLATION. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) ACCOMPLISHED THROUGH A REVIEW OF THE PATIENT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE PATIENT DEATH AND TREATMENT EVENT. EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) DID NOT INDICATE ANY DEVICE MALFUNCTIONS. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CONTRIBUTED TO OR CAUSED THE PATIENT DEATH. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 10/08/2012 - REUSE; ELECTRODE BELT SN (B)(4): 11/23/2011 - REUSE.

    Additional Manufacturer Narrative · 1

    FOLLOW UP DEVICE EVALUATION: DEVICE EVALUATION OF BELT SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE BELT FAILED INCOMING THERAPY ELECTRODE RECOGNITION TESTING. UPON EVALUATION, THERE WAS AN OPEN PULSE WIRE IN THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) AND ECG ELECTRODE B. THE CAUSE OF THE TEST FAILURE IS THE OPEN PULSE WIRE. THE ROOT CAUSE OF THE OPEN PULSE WIRE IS EXCESSIVE FORCE PLACED ON THE CABLE. THERE IS NO INFORMATION TO SUGGEST THAT THE DAMAGE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE PATIENT WAS IN A NON-LIFE SUSTAINING RHYTHM PRIOR TO AND AFTER THE SHOCKS THAT WERE DELIVERED. THE DAMAGE IS CONSISTENT WITH THE REPORTED CPR EFFORTS. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE MONITOR WAS FOUND TO BE FULLY FUNCTIONAL AND ABLE TO DETECT AN ARRHYTHMIA AND DELIVER A TREATMENT DEFIBRILLATION. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) ACCOMPLISHED THROUGH A REVIEW OF THE PATIENT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE PATIENT DEATH AND TREATMENT EVENT. EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) DID NOT INDICATE ANY DEVICE MALFUNCTIONS. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CONTRIBUTED TO OR CAUSED THE PATIENT DEATH. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 10/08/2012 - REUSE. ELECTRODE BELT SN (B)(4): 11/23/2011 - REUSE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2015. THE PATIENT EXPERIENCED AN INAPPROPRIATE TREATMENT EVENT. THE PATIENT WAS NOT CONSCIOUS AT THE TIME OF THE EVENT. DOWNLOADED ECG DATA WAS ANALYZED BY A ZOLL ECG TECHNICIAN. THE RHYTHM PRIOR TO THE INAPPROPRIATE TREATMENTS AT 13:58:26 WAS ASYSTOLE. AT 13:59:37, 14:30:34 AND 14:30:59 THE PATIENT RECEIVED INAPPROPRIATE TREATMENTS. THE RHYTHM AT THE TIME OF EACH OF THE INAPPROPRIATE TREATMENTS WAS ASYSTOLE. OVER SENSING A SMALL CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTIONS. AT 14:31:11 A NON-TREATABLE RHYTHM OF ASYSTOLE WAS DETECTED. A REVIEW OF THE DOWNLOADED DATA CONFIRMS THAT THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PATIENT PASSED AWAY ON (B)(6) 2015.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2015. THE PATIENT EXPERIENCED AN INAPPROPRIATE TREATMENT EVENT. THE PATIENT WAS NOT CONSCIOUS AT THE TIME OF THE EVENT. DOWNLOADED ECG DATA WAS ANALYZED BY A ZOLL ECG TECHNICIAN. THE RHYTHM PRIOR TO THE INAPPROPRIATE TREATMENTS AT 13:58:26 WAS ASYSTOLE. AT 13:59:37, 14:30:34 AND 14:30:59 THE PATIENT RECEIVED INAPPROPRIATE TREATMENTS. THE RHYTHM AT THE TIME OF EACH OF THE INAPPROPRIATE TREATMENTS WAS ASYSTOLE. OVER SENSING A SMALL CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTIONS. AT 14:31:11 A NON-TREATABLE RHYTHM OF ASYSTOLE WAS DETECTED. A REVIEW OF THE DOWNLOADED DATA CONFIRMS THAT THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PATIENT PASSED AWAY ON (B)(6) 2015 ------- ADDITIONAL INFORMATION 11/13/2015 CPR RESUSCITATION EFFORTS WERE REPORTEDLY PERFORMED ON THE PATIENT DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501097 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| O