BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040889 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00783
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 10, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC REPRESENTATIVE ADVISED THE HOSPITAL TO BRING THE PATIENT BACK FOR FURTHER REVIEW AND FOR INDUCTION TESTING TO TEST THE CIRCUIT AND LEAD INTEGRITY. AT THIS TIME, THIS RV LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH A SHOCK IMPEDANCE MEASUREMENT ABOVE 125 OHMS. THE SHOCK IMPEDANCE MEASUREMENTS HAVE RANGED BETWEEN 90 TO 105 OHMS AT PREVIOUS PATIENT FOLLOW UPS. ALL PARAMETERS ON THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ALL RV LEAD MEASUREMENTS WERE STABLE AND WITHIN NORMAL LIMITS. NO NOISE WAS NOTED ON THE ELECTROCARDIOGRAMS AND NO EVENTS HAVE BEEN STORED IN THE ICD'S ARRHYTHMIA LOGBOOK. IN ADDITION, NO INDUCTION TESTING WAS PERFORMED DURING THE FOLLOW UP TO ASCERTAIN THE TRUE SHOCK IMPEDANCE MEASUREMENT. 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