BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1006207 · Received March 3, 2008

    Report

    Report Number
    3002158293-2008-00080
    Event Type
    Death
    Date Received
    March 3, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 29, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DEVICE, MONITOR. ELECTRODE BELT - 06/2006. DEVICE EVAL SUMMARY: DEVICE EVALUATIONS OF MONITOR AND ELECTRODE BELT HAVE BEEN COMPLETED. MONITOR AND ELECTRODE BELT WERE ALL FOUND TO BE FUNCTIONALLY NORMAL. THEY WERE RESTOCKED. THE GARMENT WAS ALSO EVALUATED FOR BROKEN SNAPS OR HOOKS. THE GARMENT WAS FULLY FUNCTIONAL. CONCLUSION: VENTRICULAR FIBRILLATION WAS PROPERLY DETECTED THE MORNING OF THE PT'S DEMISE. THE DETECTION HALTED DUE TO SIGNAL CORRUPTION (CLIPPING), EVIDENT ON THE ECG. SECONDS LATER, THE ALGORITHM FLAGS RECORDED LOSS OF ECG ELECTRODE CONTACT WITH THE SKIN. ALARMS TO CHECK THE ELECTRODE CONTACT WERE GIVEN. ARRHYTHMIA DETECTION WILL NOT OCCUR WHEN BOTH CHANNELS ARE DETERMINED TO BE UNUSABLE. THE PT APPEARS TO HAVE BEEN FOUND WITH THE GARMENT UNCLIPPED, BESIDE THE BED. THE PT APPEARS TO HAVE UNCLIPPED THE GARMENT WHEN THE ALARMS STARTED OR WAS NOT WEARING THE GARMENT PROPERLY. THE EQUIPMENT IS NOT YET AVAILABLE FOR EXAMINATION.

    Description of Event or Problem · 1

    SUPPORT RECEIVED A CALL FROM THE TERRITORY MANAGER STATING THAT A MALE PT HAD PASSED IN 2008. TERRITORY MGR HAD THE DEVICE AND DID A DOWNLOAD. SUPPORT SAW AN AUTOMATIC EVENT THE SAME DAY, A 4:32:10 AM. FLAGS INDICATED AN ARRHYTHMIA DETECTED AT 4:32:10 AND NO ARRHYTHMIA AT 4:32:25 FOLLOWED BY DUEL LEAD NOISE AT 4:37:51. SUPPORT SAW THE ELECTRODE BELT REMOVED 11:24:08. THE BATTERY WAS PULLED THE NEXT DAY AT 15:44:47. SUPPORT SPOKE TO CORONER WHO STATED, THAT HE REMOVED THE BATTERY, AND THAT HE FOUND THE BODY SLUMPED NEXT TO THE BED WITH THE GARMENT DISCONNECTED AT THE FRONT CLIPS. SUPPORT SPOKE TO ENGINEERING ABOUT THE FLAGS WHO STATED, THEY ALSO SAW DUEL LEAD FALLOFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death