BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2173331 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11247
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 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

    MOST RECENTLY, THE PATIENT WAS INAPPROPRIATELY SHOCKED FOR DOUBLE COUNTING OF FARFIELD ATRIAL SIGNALS WHICH MANIFESTED AS R-WAVES DIMINISHED OVER TIME. THE IMPEDANCE AND THRESHOLD MEASUREMENTS OF THE RV LEAD WERE NOTED AS STABLE. HOWEVER, THE FOLLOWING PHYSICIAN DETERMINED TO HAVE THE SYSTEM EXTRACTED AS A RESULT OF THE SENSING ISSUE. TO DATE, NONE OF THESE MEDICAL DEVICES HAVE BEEN RETURNED TO BOSTON SCIENTIFIC. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS BEYOND THE NECESSARY SURGICAL INTERVENTION. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THE NON-BSC RIGHT ATRIAL AND AND BSC RIGHT VENTRICULAR LEAD DID EXHIBIT OVERSENSING LEADING TO INAPPROPRIATE SHOCK THERAPY.

    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 52 YR Required Intervention 1388T| E110| 4470| 0181| T165| 0154| 1861