BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5745825 · Received June 23, 2016

    Report

    Report Number
    3008642652-2016-04289
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    May 27, 2016
    Report Date
    June 30, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOWNLOAD DATA DID REVEAL A "GEL PREVIOUSLY RELEASED" EVENT WITHOUT A PRIOR "GEL RELEASE" EVENT. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM ("ADD GEL" MESSAGES) WAS CONFIRMED. UPON INVESTIGATION, THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO THE REAR THERAPY ELECTRODES WAS PULLED FROM THE STRAIN RELIEF. THE CAUSE FOR THE FAILURE WAS THE STRAINED CABLE. THE ROOT CAUSE FOR THE STRAINED CABLE WAS EXCESSIVE FORCE. EVALUATION METHOD: BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE AS WELL AS THE BLUE(TM) DEFIBRILLATION GEL.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY ELECTRODE BELT SN (B)(4) IS CURRENTLY UNDER EVALUATION AT ZOLL MANUFACTURING. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF THE EVALUATION. EVALUATION METHOD: BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE AS WELL AS THE BLUE DEFIBRILLATION GEL.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT ALLEGEDLY "BROKE HIS TEETH AFTER RECEIVING A DRY TREATMENT FROM THE LIFEVEST." THE PATIENT CONFIRMED THAT NO GEL WAS PRESENT FOLLOWING THE REPORTED EVENT, BUT DID REPORT RECEIVING AN "ADD GEL" MESSAGE. REVIEW OF THE DOWNLOAD DATA INDICATES THAT NO TREATABLE ARRHYTHMIAS WERE DETECTED, AND THEREFORE, NO TREATMENT SHOCK WAS REQUIRED TO BE DELIVERED TO THE PATIENT. THE CAUSE OF THE REPORTED BROKEN TEETH IS UNKNOWN. THE DOWNLOAD DATA DID REVEAL A "GEL PREVIOUSLY RELEASED" EVENT WITHOUT A PRIOR "GEL RELEASE" EVENT. THE ELECTRODE BELT INVOLVED IN THE REPORTED EVENT WAS RETURNED AND EVALUATION HAS BEEN COMPLETED. THE EVALUATION CONFIRMED THAT THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) AND REAR THERAPY ELECTRODE (TE) WAS PULLED FROM THE DN STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH A "GEL PREVIOUSLY RELEASED" EVENT WITHOUT A PRIOR "GEL RELEASE EVENT." IN ADDITION, THE REPORTED "ADD GEL' MESSAGES" ARE EXPECTED WHEN A "GEL PREVIOUSLY RELEASED" EVENT IS RECORDED.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT ALLEGEDLY "BROKE HIS TEETH AFTER RECEIVING A DRY TREATMENT FROM THE LIFEVEST." THE PATIENT CONFIRMED THAT NO GEL WAS PRESENT FOLLOWING THE REPORTED EVENT, BUT DID REPORT RECEIVING AN "ADD GEL" MESSAGE. REVIEW OF THE DOWNLOAD DATA INDICATES THAT NO TREATABLE ARRHYTHMIAS WERE DETECTED, AND THEREFORE, NO TREATMENT SHOCK WAS REQUIRED TO BE DELIVERED TO THE PATIENT. THE CAUSE OF THE REPORTED BROKEN TEETH IS UNKNOWN. THE DOWNLOAD DATA DID REVEAL A "GEL PREVIOUSLY RELEASED" EVENT WITHOUT A PRIOR "GEL RELEASE" EVENT. THE ELECTRODE BELT INVOLVED IN THE REPORTED EVENT WAS RETURNED AND EVALUATION IS CURRENTLY UNDERWAY. INCOMING CONDITION NOTES THAT THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) AND REAR THERAPY ELECTRODE (TE) WAS PULLED FROM THE DN STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH A "GEL PREVIOUSLY RELEASED" EVENT WITHOUT A PRIOR "GEL RELEASE EVENT." IN ADDITION, THE REPORTED "ADD GEL' MESSAGES" ARE EXPECTED WHEN A "GEL PREVIOUSLY RELEASED" EVENT IS RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398660 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other