BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4262496 · Received November 14, 2014

    Report

    Report Number
    3008642652-2014-04107
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    November 7, 2009
    Report Date
    November 13, 2014
    Manufacturer
    ZOLL MANUFACTURING 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

    BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE AS WELL AS THE BLUE DEFIBRILLATION GEL. DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WERE BOTH FULLY FUNCTIONAL UPON RECEIPT. MONITOR SN (B)(4): (B)(6) 2009 (INITIAL USE). ELECTRODE BELTS SN (B)(4): (B)(6) 2009 (INITIAL USE).

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST COMPLAINTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. A PT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT ON 10/30/2009 TO REPORT THAT A (B)(4) YEAR OLD MALE PT LEFT HER A MESSAGE REPORTING THAT HE WAS DEVELOPING A RASH ON HIS BACK. ZOLL CUSTOMER SUPPORT NOTIFIED PSR THAT A CUSTOMER SUPPORT REPRESENTATIVE WOULD FOLLOW-UP WITH THE PT. ZOLL CUSTOMER SUPPORT ATTEMPTED FOLLOW UP ON (B)(6) 2009. FOLLOW-UP WITH THE PT'S DAUGHTER ON (B)(6) 2009 INDICATES THE PT PASSED AWAY ON (B)(6) 2009. THE DAUGHTER REPORTED THAT THE PT'S DEATH WAS CARDIAC RELATED, AND HE WAS NOT WEARING THE LIFEVEST BECAUSE OF THE RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738823 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death