BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173276 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01534
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 11, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (GEL PREVIOUSLY RELEASED FLAGS AND HIGH IMPEDANCE FLAGS) WAS CONFIRMED. UPON INVESTIGATION, THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WAS PULLED FROM THE STRAIN RELIEF. THIS RESULTED IN AN INTERMITTENT CONNECTION BETWEEN THE CABLE AND DN. THE CAUSE FOR THE FLAGS WAS THE DAMAGED CABLE. THE ROOT CAUSE OF THE DAMAGED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    UPON REVIEW OF A (B)(6) MALE PATIENT'S FLAG FILES, ZOLL CUSTOMER SUPPORT REPORTED "GEL PREVIOUSLY RELEASED" FLAGS WITHOUT "GEL RELEASED" FLAGS AS WELL AS HIGH IMPEDANCE FLAGS. THE PATIENT WAS CONTACTED AND ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254050 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR