BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3791081 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10501
    Event Type
    Death
    Date Received
    May 5, 2014
    Date of Event
    April 28, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO A CARDIAC RELATED ISSUE. 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.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF PROGRESSIVE SHORTNESS OF BREATH. THE PATIENT WAS DIAGNOSED WITH COPD EXACERBATION, ACUTE CHRONIC DIASTOLIC HEART FAILURE, CHRONIC RENAL FAILURE, AND PNEUMONIA. PATIENT WAS PLACED ON MEDICATION AND HOSPITALIZED. WHILE IN THE HOSPITAL THE PATIENT HAD EPISODES OF VT/VF. IT WAS NOTED THAT THE PATIENTS DEVICE DISCHARGED MULTIPLE TIMES. THE PATIENT WAS UNRESPONSIVE TO RESUSCITATION ATTEMPTS AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268787 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death (B)(4)