BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213031 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10147
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    June 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WILL BE REPLACED IN THE NEAR FUTURE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD BEEN EXHIBITING INCREASED PACING IMPEDANCE MEASUREMENTS WHICH WERE REPORTED TO BE GREATER THAN 2000 OHMS. THRESHOLD AND SENSING MEASUREMENTS REMAINED UNCHANGED. A LEAD REVISION IS BEING PERFORMED IN THE NEAR FUTURE TO REPLACE THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313496 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR E102| 0148