BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1863623 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15737
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION IS PROVIDED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE WITH THIS RIGHT VENTRICULAR (RV) LEAD, DIFFICULTY WAS EXPERIENCED WITH IMPLANT. THE PATIENT BECAME AGITATED WHICH REQUIRED ADDITIONAL ANESTHESIA ADMINISTERED. THE PATIENT REQUIRED EXTERNAL CARDIAC CONVERSION SEVERAL TIMES DURING THE PROCEDURE. THE PROCEDURE WAS ABORTED, THE LEAD WAS NOT IMPLANTED, AND A PERICARDIAL EFFUSION WAS LATER DIAGNOSED.

    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 Life Threatening| R