BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952750 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23610
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 LATITUDE DETECTED A HIGH RIGHT VENTRICULAR (RV) IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. THE PATIENT WAS BROUGHT INTO THE CLINIC AND OUT OF RANGE MEASUREMENTS COULD NOT BE REPRODUCED THROUGH ISOMETRICS. NO OBSERVATION OF OVERSENSING OR INAPPROPRIATE SHOCKS WERE NOTED. TECHNICAL SERVICES DISCUSSED RECOMMENDATIONS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    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 80 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)