BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1944993 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19743
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 5, 2010
    Report Date
    October 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE (FR) INDICATED THAT THE PATIENT WAS SEEN IN OFFICE AND IS BEING FOLLOWED REGULARLY. THE SYSTEM WAS TESTED AND IT WAS FOUND THAT EVERYTHING WAS WORKING APPROPRIATELY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION VIA A LATITUDE RED ALERT THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THAT ASSOCIATED RIGHT VENTRICULAR (RV) LEAD DISPLAYED A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION HAS BEEN MADE. NO ADVERSE PATIENT EFFECTS WERE 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 57 YR T165| 4135| 0180