BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2082487 · Received May 10, 2011

    Report

    Report Number
    2124215-2011-08133
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    January 5, 2011
    Report Date
    May 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN IN-DEPTH REVIEW OF THIS CASE BY OUR PATIENT SAFETY ADVISORY BOARD WAS PERFORMED. THE REVIEW CONCLUDED THE EVIDENCE INDICATED THE OBSERVED OUT-OF-RANGE IMPEDANCE WAS LIKELY CONSISTENT WITH NORMAL OPERATION. THE STABLE THRESHOLDS, ABSENCE OF NOISE OR DRAMATIC IMPEDANCE, AS WELL THE NORMAL AMPLITUDE MEASUREMENTS, INDICATED THE HIGH IMPEDANCE WAS LIKELY NOT RELATED TO A CONNECTION ISSUE OR PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE FOLLOW UP OUT OF RANGE PACING IMPEDANCES WERE SEEN ON THE RIGHT VENTRICULAR (RV) LEAD AND A 'CHECK RV LEAD' ALERT APPEARED. DAILY MEASUREMENTS SHOWED HIGH IMPEDANCES WHICH REMAINED WITHIN RANGE SINCE THE DEVICE CHANGE-OUT PROCEDURE. ALL OTHER MEASUREMENTS WERE NORMAL AND NO NOISE WAS SEEN ON THE ELECTROCARDIOGRAM. AT THIS TIME THE PHYSICIAN ELECTED NOT TO PERFORM A REVISION PROCEDURE BUT INSTEAD TO MONITOR THIS PATIENT CLOSELY ON LATITUDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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