BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY 2

    MDR report key: 2052290 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-06486
    Event Type
    Death
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE AREA BOSTON SCIENTIFIC FIELD REPRESENTATIVE SUBSEQUENTLY REPORTED THAT THE PATIENT PASSED AWAY AFTER BEING ADMITTED TO A HOSPITAL. WHILE HOSPITALIZED, THE PATIENT LATER WAS DECLARED DO NOT RESUSCITATE AND DIAGNOSED WITH ELEVATED POTASSIUM LEVELS, APICAL THROMBUS AND RENAL FAILURE. NO ADDITIONAL INFORMATION WAS AVAILABLE. WHILE IT IS UNLIKELY THAT THE DEVICE'S ADVISORY STATUS CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, WITHOUT A REPORTED CAUSE OF DEATH OR THE DEVICE'S AVAILABILITY FOR ANALYSIS, WE CANNOT REFUTE THE ALLEGATION THAT THE DEVICE WAS ASSOCIATED WITH THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PATIENT'S SPOUSE THAT THE PATIENT WITH THIS IMPLANTED DEVICE HAD RECENTLY PASSED AWAY, AND THE SPOUSE BELIEVES THE DEATH WAS RELATED TO THE DEVICE BEING PART OF THE (B)(6) 2007 SHORTENED REPLACEMENT WINDOW ADVISORY POPULATION. THE SPOUSE PROVIDED NO ADDITIONAL INFORMATION AND TERMINATED THE TELEPHONE CALL AFTER BEING REFERRED BY A BOSTON SCIENTIFIC CUSTOMER SERVICE REPRESENTATIVE TO THE PATIENT'S PHYSICIAN FOR INFORMATION REGARDING THE PATIENT'S MEDICAL ISSUES AND CAUSE OF DEATH, AND DEVICE RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death T165| 4480| 4035| 0158