BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2051805 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03437
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, EVIDENCE SUGGESTS BOTH OF THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. THE INVESTIGATION REMAINS OPEN AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID EXHIBIT HIGH PACE IMPEDANCE. RV LEAD IMPEDANCE WAS DETERMINED TO BE GREATER THAN 2000 OHMS PACE IMPEDANCE, UP FROM ABOUT 1300 OHMS ABOUT ONE YEAR AGO. THE LOCAL AREA SALES REPRESENTATIVE NOTED THAT THE RISE IN IMPEDANCE HAD BEEN GRADUAL. THE PATIENT WAS GOING TO BE CALLED FOR A DEVICE CHECK. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR 1860| 0148| E102