BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2792689 · Received October 16, 2012

    Report

    Report Number
    2124215-2012-14023
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 WITH SEPSIS WAS FOUND TO HAVE HAD INTERMITTENT LOSS OF RIGHT VENTRICULAR (RV) LEAD CAPTURE WITH AN ESCAPE RATE OF 30BMP. THE THRESHOLDS WERE ELEVATED SO THE DEVICE PROGRAMMING WAS CHANGED TO ALLEVIATE. THE DEVICE AND LEAD REMAIN IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    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 1200 MO 1705| 0144| 1851| 0048| 0072| 1746| 1861| T165| 6836| 4461