BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1853910 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15476
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT HAS BEEN MADE TO GATHER ADDITIONAL DETAIL ABOUT THIS EVENT. CURRENT RECORDS SUGGEST THAT THIS DEVICE REMAINS IN SERVICE AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED. A CLINICIAN NOTED AN OUT OF RANGE TELEMETRY MESSAGE WHEN ATTEMPTING TO INTERROGATE THE DEVICE. THE CLINICIAN ATTEMPTED TO TROUBLESHOOT THE SITUATION VIA RECOMMENDATIONS FROM THE BOSTON SCIENTIFIC TECHNICAL SERVICES DEPARTMENT, BUT THE DEVICE COULD STILL NOT BE INTERROGATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS OBSERVATION.

    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 68 YR 4462| 101-10| 1851| 497-19| T165| 438-10