BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2192641 · Received August 5, 2011

    Report

    Report Number
    2124215-2011-13365
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT PASSED AWAY; THE PATIENT'S PHYSICIAN REPORTED TO A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THE DEATH WAS NOT DUE TO CARDIAC ISSUES. THE REPRESENTATIVE REPORTED THAT A POST-MORTEM DEVICE CHECK WAS NOT REQUESTED, AND IT WAS BELIEVED THAT THE DEVICE AND LEAD WERE NOT EXPLANTED FOLLOWING THE PATIENT'S DEATH. THE REPRESENTATIVE CONFIRMED THAT THERE WERE NO ALLEGATIONS OR SUSPICIONS THAT THE DEVICE OR LEAD CAUSED OR CONTRIBUTED TO THE SEPTICEMIA OR THE PATIENT'S DEATH. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE HAD BEEN ADMITTED TO A HOSPITAL WITH A DIAGNOSIS OF SEPTICEMIA AND SUBSEQUENTLY WENT ASYSTOLIC. A DEVICE INTERROGATION SHOWED EVIDENCE OF HIGH OUT-OF-RANGE PACE IMPEDANCES OVER THE (B)(6) FOR THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD, AND RV CAPTURE COULD NOT BE OBTAINED. IT WAS REPORTED THAT THE PATIENT HAD BEEN NON-COMPLIANT, AND HAD NOT BEEN SEEN CLINICALLY FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening (B)(4)| (B)(4)