BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140494 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17231
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS RETURNED IN TWO SEGMENTS, SEVERED 115 MILLIMETERS (MM) FROM THE TERMINAL PIN WITH THE EXTRACTION STYLET STUCK IN THE SECOND SEGMENT OF THE LEAD. UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THAT THE SEAL RING WAS PUSHED BACK AT 7 MM ON THE TERMINAL PIN, THE PROXIMAL END OF THE PROXIMAL SPRING ELECTRODE WAS STRETCHED AND SEPARATED FROM THE LEAD BODY INSULATION AND DRIED BLOOD/BODY FLUID WAS NOTED IN THE LUMEN. ADDITIONALLY, ANALYSIS NOTED ABRASIONS ON THE INSULATION ON THE PROXIMAL PORTION OF THE LEAD 375-379 MM FROM THE TERMINAL PIN AND ON THE DISTAL PORTION AT 581 MM FROM THE TERMINAL PIN THAT WAS CONSISTENT WITH LEAD ON LEAD ABRASION. LABORATORY ANALYSIS CONFIRMED THE CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF NOISE WHICH DID NOT LEAD TO PACING INHIBITION. THE LEAD WAS EXPLANTED AND WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619327 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 1861| 0180| 4053| 0184| 0148| E110