BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY ASSURA DR, DF4 CONNECTOR

    MDR report key: 2984573 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00543
    Event Type
    Death
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING POST IMPLANT FOLLOW UP, SLIGHTLY ELEVATED CAPTURE THRESHOLD WAS OBSERVED, BUT THE PHYSICIAN FELT IT WAS NOT ABNORMAL. TWO WEEKS LATER, THE PATIENT PRESENTED TO THE HOSPITAL WITH PERICARDIAL EFFUSION AND TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE AT THAT TIME, BUT LATER EXPIRED. THE PHYSICIAN SUSPECTS THE PATIENT DIED OF SEPSIS, AND THAT PERFORATION WAS NOT THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87462 FORTIFY ASSURA DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death (B)(4)