BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151731 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06196
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A PATIENT FOLLOW UP, THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD REPORTED FEELING CHEST PAIN. AN ECHOCARDIOGRAM WAS PERFORMED AND IT WAS DISCOVERED THAT THE PATIENT HAD A PERICARDIAL EFFUSION. IT WAS BELIEVED THAT THE EFFUSION WAS CAUSED BY A PERFORATION OF THE HEART WALL CLOSE TO THE APEX. THE PATIENT WAS TREATED FOR THE EFFUSION AND RESPONDED WELL. HOWEVER, IT WAS NOTED THAT THE PACING IMPEDANCE AND SENSING MEASUREMENTS HAD DECREASED AND THERE WAS COMPLETE LOSS OF CAPTURE AT THE MAXIMUM OUTPUTS. A REVISION WILL BE PERFORMED TO REPOSITION THE LEAD. 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 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L