BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950974 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23636
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 20, 2010
    Report Date
    December 30, 2011
    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

    THE PHYSICIAN WAS NOTIFIED AND A FOLLOW UP WAS BEING PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AND THIS CRT-D REMAINS IMPLANTED. ONCE THE OUTCOME OF THE FOLLOW UP BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT ANOTHER OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS DETECTED ON THIS RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PHYSICIAN WAS NOTIFIED ABOUT THE MEASUREMENT. ATTEMPTS TO OBTAIN MORE INFORMATION ON THIS LEAD HAVE NOT BEEN SUCCESSFUL. 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 SYSTEM AFTER THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED A HIGH SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR DEFIBRILLATION LEAD. 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 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 0181| F102