BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 4173847 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16723
    Event Type
    Death
    Date Received
    October 15, 2014
    Date of Event
    September 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. DEVICE INTERROGATION POST-MORTEM REVEALED A NON-SUSTAINED VT/VF EPISODE WITH A DECREASE IN R-WAVE AMPLITUDE RESULTING IN UNDERSENSING ON THE NEAR-FIELD CHANNEL. IT WAS ALSO NOTED THAT THE PATIENT HAD NOT BEEN SEEN FOR A DEVICE CHECK IN MORE THAN A YEAR. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655656 FORTIFY ASSURA VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death