BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951473 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23039
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 26, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD'S REPORTING STATUS IS CHANGED TO SERIOUS INJURY FROM MALFUNCTION DUE TO SURGICAL INTERVENTION TO ACHIEVE RESOLUTION.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT SUBSEQUENTLY WAS SEEN CLINICALLY. THE DEVICE-LEAD CONNECTIONS WERE CHECKED AND FOUND TO BE SECURE. THE RV LEAD WAS THEN REMOVED FROM THE HEADER, AND A RED FILM WAS OBSERVED ON THE TERMINAL PIN. THE PIN AND HEADER PORT WERE CLEANED, AND THE LEAD REINSERTED. THE ENSUING MEASUREMENTS WERE NORMAL AND STABLE. DEFIBRILLATION THRESHOLD TESTING (DFT) WAS SUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC RIGHT VENTRICULAR (RV) LEAD AND A RECENTLY-IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WERE ASSOCIATED WITH A REMOTE MONITORING ALERT FOR A HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENT.

    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 63 YR Required Intervention 0158| N119| 4543| 4470