BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 4262470 · Received November 14, 2014

    Report

    Report Number
    3008642652-2014-04120
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    November 2, 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

    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. PER REVIEW OF THE TREATMENT EVENT, THE DEVICE DETECTED VT/VF PRIOR TO ASYSTOLE. THE RHYTHM SHOWN ON THE SS CHANNEL HAS DC OFFSET CAUSED BY NOISE. HOWEVER, THE FB CHANNEL CLEARLY SHOWS A TREATABLE ARRHYTHMIA. THE DETECTION STOPPED WHEN THE COMPLEXES BECAME MORE ERRATIC, AND THE DETECTED RATE DROPPED BELOW 180 BPM PROGRAMMED THRESHOLD SET FOR VT. MONITOR SN (B)(4): (B)(6) 2006 (REUSE). ELECTRODE BELTS SN (B)(4): (B)(6) 2006 (REUSE).

    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 ZOLL TERRITORY MANAGER CONTACTED ZOLL CUSTOMER SUPPORT OT REPORT THAT A (B)(6) YEAR OLD FEMALE PT PASSED AWAY ON (B)(6) 2009. THE PT WAS AT (B)(6) AT THE TIME OF PASSING. THE TM REPORTED THAT THE PT WAS IN VENTRICULAR FIBRILLATION FOR 583 SECONDS PRIOR TO PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738962 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death