BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIC II VR

    MDR report key: 3220379 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04664
    Event Type
    Death
    Date Received
    July 11, 2013
    Date of Event
    October 19, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319848 EPIC II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-158 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death 7022/65, ADT12022