BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2161569 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07362
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSVENOUS LEAD, THE PHYSICIAN NOTED IMPEDANCE LEVELS OF 2000 OHMS. THE LEAD WAS REPOSITIONED WITH ADEQUATE LEAD MEASUREMENTS. THE PHYSICIAN THEN NOTED A BLUNTED CARDIAC BORDER, AND A SUBSEQUENT ECHOCARDIOGRAM SHOWED A SUSPECTED PERFORATION WITH FLUID IN THE PERICARDIUM. THE LEAD WAS REPOSITIONED TO THE SEPTAL WALL AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENT HAS SINCE BEEN DIS-CHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L E110| 0185| 4136