BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951060 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-11273
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 11, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ABRASIONS WERE NOTED THROUGH THE TRILUMEN INSULATION APPROXIMATELY 280-287 MILLIMETERS (MM) AND 196-202 MM FROM THE TERMINAL PIN. THE ABRASIONS WERE SMOOTH AND CONCAVE. DUE TO THE LOCATIONS AND TYPE OF DAMAGE THESE WERE LIKELY CAUSED BY LEAD-ON-LEAD CONTACT COUPLED WITH MOVEMENT. AN INSULATION ABRASION THROUGH TO A SENSING CONDUCTOR COULD CAUSE NOISE TO BE SEEN BY THE DEVICE. LABORATORY TESTING CONFIRMED THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD REGISTERED MORE THAN 100 OF NOISE EPISODES. HOWEVER, AMPLITUDE, IMPEDANCE AND THRESHOLD MEASUREMENTS WERE WITHIN NORMAL RANGE. A LEAD REVISION WAS PERFORMED TO REPLACE THIS LEAD. THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALSO REPLACED EVEN THE DEVICE WAS NOT YET IN ERI TO TAKE ADVANTAGE OF THE SURGICAL LEAD REVISION. THERE WAS NO ALLEGATION AGAINST THE ICD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS SUCCESSFULLY REPLACED AND ALL FINAL MEASUREMENTS WERE OF NORMAL RANGE. THIS LEAD WILL BE RETURNED. ADDITIONAL INFORMATION RECEIVED AND CONFIRMED THAT THE NOISE RESULTED TO OVERSENSING; HOWEVER, THERE WAS NO PACING INHIBITION THAT LEAD TO ASYSTOLE AS THE PATIENT WAS NOT PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427643 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 0175| 0695| F140| T175