BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 4130801 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16238
    Event Type
    Death
    Date Received
    September 30, 2014
    Date of Event
    April 9, 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
    WV, US
    Reporter Occupation
    OTHER

    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. 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.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE PATIENT WAS ADMITTED TO THE ICU AFTER PRESENTING TO PHYSICIAN WITH SHORTNESS OF BREATH AND LEG INFECTION POST AMPUTATION. PATIENT WAS ALSO FOUND TO HAVE WORSENING RENAL FAILURE, CONGESTIVE HEART FAILURE WITH AN EF OF 10 PERCENT AMONG OTHER NON-RELATED ISSUES. THE PATIENT WAS GIVEN A POOR PROGNOSIS DUE TO WORSENING CONDITIONS. THE PATIENT WAS PLACED ON DNR STATUS AND WAS DISCHARGED HOME. THE DEATH CERTIFICATE LISTED THE CAUSE OF DEATH AS CORONARY ARTERY DISEASE (CAD), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), RESPIRATORY FAILURE, AND RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608468 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death 7120Q/BNP015387, 1888/CAD068430, 1258/BRP017774