BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1944736 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20332
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SURGICAL REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE POCKET WAS REOPENED AND THE DEVICE AND RV LEAD WERE TESTED. DEVICE CONNECTIONS WERE CONFIRMED TO BE SECURE. THE RV LEAD WAS THEN TESTED VIA PACING SYSTEM ANALYZER (PSA) AND FOUND TO BE EXHIBITING NORMAL MEASUREMENTS. THE PHYSICIAN THEN ELECTED TO SURGICALLY CAP THIS RV LEAD AND IMPLANT A NEW RV LEAD. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DETECTED PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS, TRIGGERING A LATITUDE RED ALERT. THE PATIENT HAD REPORTEDLY FALLEN DURING THE PREVIOUS WEEK, AND CONCERN WAS EXPRESSED THAT THE FALL MAY HAVE DAMAGED THE PATIENT'S RV LEAD. RV CAPTURE AND SENSING REMAINED ACCEPTABLE, BUT SOME RV CHANNEL NOISE WAS ELICITED DURING CLINICAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R E102| 0184