BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951410 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22910
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 25, 2010
    Report Date
    December 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD AND DEVICE REMAIN IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BE OBTAINED, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. DURING THE DEVICE REPLACEMENT PROCEDURE, THE PACE/SENSE PORTION OF THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, A REVIEW OF THE ARRHYTHMIA LOG BOOK REVEALED AN EPISODE OF NOISE ON THE RIGHT VENTRICULAR PACE/SENSE LEAD RESULTING IN PACING INHIBITION APPROXIMATELY FIVE SECONDS. THE PATIENT WITH THIS LEAD EXPERIENCED NO ADVERSE PATIENT SYMPTOMS. THE NOISE COULD NOT BE REPRODUCED BY ISOMETRICS. FURTHER MONITORING OF THE LEAD WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other