BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042183 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01126
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV LEAD WAS SUCCESSFULLY REPLACED, AND WILL BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANLAYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PORTION OF THE RV LEAD WITH THE ELECRODE TIP WAS SURGICALLY ABANDONED, AND THE OTHER SECTION OF THE LEAD WAS TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS, BUT WAS NEVER RECEIVED. THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. PLEASE ACCEPT THIS AS A FINAL REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOSS OF CAPTURE, DISLODGMENT, AND AN INCREASE IN R WAVE VALUES. DURING THE REVISION PROCEDURE, THIS RV LEAD WAS CUT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    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