BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041838 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01279
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    October 19, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS LEAD REMAINS IN SERVICE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER ALERT FOR OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WAS NOTED. THE PATIENT WAS BROUGHT INTO THE CLINIC AND THE IN OFFICE IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE CLINIC ELECTED TO MONITOR THE LEAD AT THIS TIME.

    Description of Event or Problem · 1

    THE PREVIOUSLY NOTED OUT OF RANGE IMPEDANCE MEASUREMENTS WERE ONLY PACE IMPEDANCES AND NOT SHOCK IMPEDANCES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THIS LEAD REMAINS IMPLANTED. 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 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR 0158| 4087| A135| E110