BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2090912 · Received May 4, 2011

    Report

    Report Number
    3002158293-2011-00510
    Event Type
    Death
    Date Received
    May 4, 2011
    Date of Event
    March 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PT DEATH) HAS BEEN INVESTIGATED. UPON RECEIPT THE A AND B ASSEMBLY WAS TORN FROM THE DISTRIBUTION NODE, EXPOSING WIRES. THE CAUSE FOR THE DAMAGED CABLE CANNOT BE POSITIVELY DETERMINED BUT LIKELY OCCURRED AFTER THE PT PASSED AWAY AS THE ECG RECORDING OF THE ASYSTOLE EVENT SHOWED NO SIGNS OF ECG SIGNAL ARTIFACT. THERE IS NO EVIDENCE THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PT'S DEATH. THE DEVICE PROPERLY DETECTED, ALARMED, AND RECORDED A VALID ASYSTOLE EVENT LASTING 600 SECONDS ON (B)(6) 2011. ASYSTOLE IS CONSIDERED A NON-TREATABLE RHYTHM. THE DECLARED ASYSTOLE EVENT IS ATTACHED.

    Description of Event or Problem · 1

    ZOLL WAS NOTIFIED OF THE DEATH OF A (B)(6) MALE PT. THE PT WAS DISCOVERED AT HIS WORKPLACE. HIS LIFEVEST WAS ALARMING AND HE WAS UNRESPONSIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death