BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1852691 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14437
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS LATER DISCHARGE TO HOME AND ANOTHER PROCEDURE WILL BE PERFORMED AT A LATER DATE. BECAUSE THE LEAD WAS DISCARDED FOLLOWING THE IMPLANT PROCEDURE, IT WILL NOT BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANTATION OF THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD, THIS PATIENT DEVELOPED A HEMOTHORAX THAT RESULTED IN A PLEURAL EFFUSION. THE PROCEDURE WAS ABORTED AND THE LEAD DISCARDED. THE PATIENT WAS HOSPITALIZED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L