BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2011-10700

    MDR report key: 2171623 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10700
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 19, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REMAINS OPEN AT THIS TIME. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT CLARIFIED THAT THE FAULT CODE EXHIBITED REGARDED A PROGRAMMER SCREEN ERROR THAT OCCURS WHEN "SHOW LAST EPISODE" IS SELECTED TOO QUICKLY AFTER AN EPISODE HAS BEEN COMPLETED. THIS IS A KNOWN ISSUE THAT APPARENTLY ONLY OCCURS WITH DEFIBRILLATION THRESHOLDS (DFTS) TESTING AT IMPLANT. THERE IS THEREFORE, NO EVIDENCE OF A SHORTED CONDITION. ALL PRODUCTS REMAIN ACTIVELY IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT A FAULT CODE AFTER THE SHOCK ON T INDUCTION AND CONVERSION THAT MAY BE REPRESENTATIVE ON A SHORTED SHOCK CONDITION. THE BOSTON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR MORE INFORMATION BUT NONE IS AVAILABLE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVY GUIDANT PUERTO RICO BV TACHY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1