BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2040803 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01440
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    October 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE REPLACEMENT PROCEDURE WILL LIKELY BE PERFORMED IN THE NEAR FUTURE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO EXHIBITING END OF LIFE (EOL) BEHAVIOR ALONG WITH DISPLAYING A FAULT CODE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WHO'S DEVICE HAD PREVIOUSLY DECLARED EOL, HAD A REMOTE MONITORING REMINDER THAT DEVICE STILL NEEDED TO BE REPLACED AS THE PATIENT IS PACEMAKER DEPENDANT. THE FIELD REPRESENTATIVE NOTED THAT THE PATIENT WAS IN POOR HEALTH, WHICH IS WHY THE DEVICE HAD NOT BEEN REPLACED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED ABOUT THE AMOUNT OF PACING REMAINING. TS NOTED THAT POST EOL, PACING IS NOT GUARANTEED AND COULD NOT PREDICT HOW MUCH PACING WAS REMAINING.

    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 79 YR Hospitalization| R 4087| T165| 0185| 0186