BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951050 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-10705
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    April 29, 2013
    Report Date
    June 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL OBSERVATION REVEALED TRILUMEN INSULATION WAS ABRADED THROUGH EXPOSING THE CONDUCTOR COIL APPROXIMATELY 16.3-17.1 CM FROM THE TERMINAL PIN. THE DAMAGE WAS MOST LIKELY DUE TO LEAD ON CAN INTERACTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO SENSING AND NOISE PROBLEMS. IT WAS CONFIRMED THAT THERE WAS NO ASYSTOLE OR DELAYED/PROLONGED THERAPY AS A RESULT OF THE ISSUES. THE PATIENT WAS NOT PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428328 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 0296| MISMATCH| 0696