BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY QUADRA CRT-D, DF-4 CONNECTOR

    MDR report key: 3781784 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09972
    Event Type
    Death
    Date Received
    April 30, 2014
    Date of Event
    January 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    NEW INFORMATION RECEIVED NOTES THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR HYPOXIA AND DIFFICULTY BREATHING. THE CAUSE OF DEATH WAS REPORTED AS ACUTE ON CHRONIC RESPIRATORY FAILURE SECONDARY TO A COMBINATION OF CONGESTIVE HEART FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, OBSTRUCTIVE SLEEP APNEA, PULMONARY HYPERTENSION, MORBID OBESITY, AND ASPIRATION PNEUMONIA.

    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
    260298 UNIFY QUADRA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3249-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death (B)(4)