BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053214 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04252
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 15, 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

    A REVIEW OF THE LATITUDE WEBSITE CONFIRMED THAT THE SHOCK IMPEDANCE MEASUREMENTS HAVE RANGED FROM 80 TO ABOVE 125 OHMS. IT WAS ALSO CONFIRMED THAT THE MEASUREMENTS DID GO ABOVE 125 OHMS ON TWO OCCASIONS WHICH BOTH TRIGGERED RED ALERTS. THE TS REPRESENTATIVE DISCUSSED THAT A REVIEW OF THE MEASUREMENTS SHOW THAT THE SHOCK IMPEDANCES HAVE ARE WITHIN THE UPPER RANGE, MOST LIKELY DUE THE DEFIBRILLATION LEAD BEING A SINGLE COIL LEAD. THE MEASURED IMPEDANCES CAN CHANGE MORE THAN 20 OHMS ON A DAY TO DAY BASIS, MAKING IT POSSIBLE TO HAVE THE MEASURED VALUES CROSS THE 125 OHMS MEASUREMENT AND TRIGGER A RED ALERT. AT THIS TIME, THE DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN WAS NOTIFIED OF THE RED ALERT AND A CONSULTATION HAS BEEN PERFORMED. AT THIS TIME, THIS LEAD AND DEVICE REMAIN IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS ISSUED THROUGH THE LATITUDE SYSTEM AFTER THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A HIGH SHOCK IMPEDANCE MEASUREMENT ON THIS RIGHT VENTRICULAR (RV) LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE INFORMATION WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR FURTHER EVALUATION.

    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