BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2051631 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03572
    Event Type
    Death
    Date Received
    April 12, 2011
    Date of Event
    February 14, 2011
    Report Date
    May 5, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE SYSTEM WAS SUCCESSFULLY EXPLANTED AND THE PATIENT UNDERWENT HEART VALVE REPLACEMENT. HOWEVER, THIS PATIENT WAS LATER TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT OF AN INFECTION. THE PATIENT SUBSEQUENTLY, HAD FURTHER HEMODYNAMIC DETERIORATION AND RENAL FAILURE AND WAS INTUBATED. DIALYSIS WAS ALSO PERFORMED SEVERAL TIMES BUT THIS PATIENT LATER DIED DUE TO HEART FAILURE AND RENAL INSUFFICIENCY. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CRT-D DEVELOPED ENDOCARDITIS AND AN INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) EXPERIENCED AN INFECTION DUE TO ENDOCARDITIS. MEDICATION WAS GIVEN, AND AN EXPLANT PROCEDURE HAS BEEN PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O