BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1946267 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20341
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SOMETIMES EXHIBITED SPIKES ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE SPIKE WAS SENSED WHEN IT APPEARED TOWARDS THE END OF THE STIMULATION CYCLE. WHEN THE SPIKE WAS SENSED STIMULATION WAS INHIBITED. THERE WAS NO OBSERVATION OF PACING INHIBITION THAT RESULTED IN GREATER THAN 2 SECONDS. THIS PATIENT IS PACEMAKER DEPENDANT, AND IS BEING MONITORED. IT WAS NOTED THAT THE PACING IMPEDANCE HAS ALWAYS BEEN GREATER THAN 2000 OHMS, BUT THE PHYSICIAN NEVER PERFORMED A REVISION PROCEDURE OF THE ASSOCIATED ICD OR THIS RV LEAD. THE PACING IMPEDANCE WITH THE LAST PG WAS BETWEEN 1950 AND 2030 OHMS. THIS DEVICE WAS EXPLANTED DUE TO THE DEPLETION OF THE BATTERY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0148

    Patients

    Seq Age Sex Outcome Treatment
    1