BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPLORER

    MDR report key: 1728811 · Received June 17, 2010

    Report

    Report Number
    3027765-2010-00047
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    January 3, 2008
    Report Date
    January 18, 2008
    Manufacturer
    CARD GUARD SCIENTIFIC SURVIVAL LTD.
    Product Code
    DXH
    PMA / PMN Number
    K963811
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY'S INITIAL ASSESSMENT OF THIS EVENT DETERMINED THAT DUE TO THIS PARTICULAR DEVICE'S CAPABILITIES, INTENDED USE AND THE PT REQUIRED ACTIVITY TO CAPTURE AN EVENT, IT COULD NOT REASONABLY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. AFTER FURTHER REVIEW, THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. THE DEVICE WAS NOT RETURNED TO LIFEWATCH BY THE PATIENT'S FAMILY. THE DEVICE IS CURRENTLY BEING HELD BY THE PATIENT'S LEGAL COUNSEL.

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED WITH (B) (4) SERIAL NUMBER (B) (4). THE ORIGINAL BASELINE WAS ESTABLISHED ON (B) (6) 2007. TRANSMISSIONS MADE WITH THE DEVICE ON (B) (6) 2008, WERE REPORTED TO BE OF POOR QUALITY. AFTER TROUBLESHOOTING UNSUCCESSFULLY, THE TECH PLACED AN ORDER FOR A REPLACEMENT DEVICE (SERIAL (B) (4)) THAT ARRIVED ON (B) (6) 2008. THE REPLACEMENT DEVICE WAS NOT ACTIVATED FOR BASELINE SERVICE. THE PT EXPIRED IN THE EVENING BETWEEN (B) (6) 2008 AND (B) (6) 2008. AT THE TIME OF DEATH, IT COULD NOT BE DETERMINED IF THE PATIENT WAS WEARING DEVICE SERIAL NUMBER (B) (4). BOTH DEVICES HAVE NOT BEEN RETURNED FOR EVAL. THE EXPLORER DEVICE IS A PATIENT-ACTIVATED LOOPING CARDIAC EVENT MONITOR. TRANSMISSIONS ARE SENT MANUALLY BY THE PATIENT USING A PHONE. THE DEVICE IS NOT INDICATED FOR USE AS A REAL-TIME EMS SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPLORER TRANSMITTER&RECEIVERS, ELECTROCARDIOGRAPH DXH CARD GUARD SCIENTIFIC SURVIVAL LTD. FG-6106 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death