BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1954050 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24482
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WERE CONCERNS THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING AND OVERSENSING UPON REVIEW OF PRINTOUTS FROM THE DEVICE. IT WAS FURTHER STATED THAT THERE WERE PAUSES IN PACING FOR TWO TO FOUR BEATS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS BELIEVED THAT THE PATIENT WAS IN THE CLINIC DURING THE EPISODES; HOWEVER, AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 1790| T167| 4470| 1861| 0095