BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTAK PRIZM HE DR

    MDR report key: 383433 · Received February 8, 2002

    Report

    Report Number
    2124215-2002-03661
    Event Type
    Death
    Date Received
    February 8, 2002
    Date of Event
    September 26, 2001
    Report Date
    October 1, 2001
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DELIVERED SHOCKS TO THE PATIENT OVER THE WEEKEND. THE ICD WAS INTERROGATED AND IT WAS CONFIRMED THAT THE SHOCKS WERE APPROPRIATE. GUIDANT RECEIVED INFORMATION THAT THE PATIENT DIED LATER THAT SAME DAY. REVIEW OF THE STORED EGRAMS NOTED REOCURRING PVT AND EGRAM CLARITY AND AMPLITUDE DECREASED WITH DIVERTED EPISODES AND EPISODES THAT FELL OUT OF DETECTION WINDOW. ON OCTOBER 1, 2001 GUIDANT RECEIVED ADDITIONAL INFORMATION THAT INDICATED THE PHYSICIAN WAS CONCERNED THAT THE ICD'S ABILITY TO SENSE PROPERLY MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM HE DR IMPLANTABLE CARDIOVERTER DEFRIBRILLATOR LWS CARDIAC PACEMAKERS 1853 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death