BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4898624 · Received July 8, 2015

    Report

    Report Number
    3008642652-2015-04300
    Event Type
    Death
    Date Received
    July 8, 2015
    Date of Event
    June 7, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ZOLL MANUFACTURING 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 EVALUATION OF MONITOR SN (B)(4) IS UNDERWAY. AT THIS TIME THERE IS NO INDICATION OF A MONITOR MALFUNCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED SHOULD A MALFUNCTION BE DISCOVERED. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) WAS COMPLETED. UPON INVESTIGATION THE CABLE CONNECTING THE DISTRIBUTION NODE TO THE REAR THERAPY ELECTRODES WAS PULLED FROM THE STRAIN RELIEF, DAMAGING WIRES. THE ROOT CAUSE FOR THE STRAINED CABLE WAS EXCESSIVE FORCE. THERE IS NO INDICATION THAT THE DAMAGE TO THE CABLES OCCURRED DURING DEVICE USE, AS THE DEVICE WAS STILL DETECTING THE PATIENT'S ECG RHYTHM THROUGHOUT THE EVENT. IT IS LIKELY THAT THE DAMAGE RESULTED DURING DEVICE REMOVAL.

    Description of Event or Problem · 1

    A US DISTRIBUTOR REPORTED THAT THE PATIENT WAS TREATED AND PASSED AWAY ON (B)(6) 2015. THE LIFEVEST DETECTED BRADYCARDIA (5-30 BPM) DEGRADING TO ASYSTOLE AT 12:12:11. TWO TREATMENTS WERE DELIVERED AT 12:15:59 AND 12:22:58 DURING ASYSTOLE. ASYSTOLE IS CONSIDERED A NON-TREATABLE RHYTHM. OVERSENSING AND CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443380 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death