BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1954227 · Received January 10, 2011

    Report

    Report Number
    2124215-2011-00096
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AND THERE ARE NO PLANS TO REPLACE THE LEAD. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS ISSUED THROUGH THE LATITUDE MONITORING SYSTEM DUE TO A HIGH RIGHT VENTRICULAR IMPEDANCE MEASUREMENT ON THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD. THE PHYSICIAN WAS NOTIFIED OF THIS ALERT. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEFIBRILLATION LEAD HAS HAD PACING IMPEDANCES ABOVE 1,900 OHMS, BUT ALL OTHER MEASUREMENTS HAVE REMAINED STABLE. 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 0161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other