BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053078 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04681
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD BEEN FEELING A LITTLE MORE FATIGUE LATELY. AT A NORMAL DEVICE FOLLOW UP, LVP WAS NOTED BUT NO RECENT RVP WAS IDENTIFIED. SYSTEM EVALUATION NOTED THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING NO CAPTURE DESPITE MAXIMUM DEVICE OUTPUTS AND DECREASED SENSING MEASUREMENTS. THE LEAD WAS FOUND TO HAVE DISLODGED AND A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS REMOVED FROM SERVICE AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156881 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization H215| N164| 4517| 4469| 0184