BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2050211 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03261
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 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

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS 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 ROUTINE IMPLANT PROCEDURE, THE INITIAL PLACEMENT OF THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED POOR SENSING MEASUREMENTS. THE IMPLANTING PHYSICIAN REPOSITIONED THE LEAD FURTHER INTO THE RV APEX WITH ACCEPTABLE MEASUREMENTS. SOON AFTER THE PLACEMENT OF THE RV LEAD, THE PATIENT'S BLOOD PRESSURE DECREASED. AN ECHOCARDIOGRAM WAS IMMEDIATELY PERFORMED WHICH CONFIRMED TAMPONADE. A PERICARDIOCENTESIS PROCEDURE WAS PERFORMED AND THE PATIENTS' BLOOD PRESSURE RETURNED BACK TO NORMAL. THE DEVICE SYSTEM WAS IMPLANTED WITHOUT FURTHER COMPLICATION. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND WAS REPORTED TO BE IN STABLE CONDITION.

    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 Life Threatening