BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2060152 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05647
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE IMPLANT PROCEDURE, MULTIPLE ATTEMPTS WERE MADE TO POSITION THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD DUE TO INSUFFICIENT SENSING. WHEN AN ACCEPTABLE POSITION WAS FOUND, THE LEAD WAS PLACED. HOWEVER, IT WAS NOTED THAT DURING THE PREVIOUS ATTEMPTS TO POSITION THE LEAD, THE LEAD PERFORATED THE PATIENT'S RIGHT VENTRICLE, CAUSING A PERICARDIAL EFFUSION. ARTERIAL BLOOD PRESSURE DECLINED SLOWLY BUT STEADILY, AND AN ULTRASOUND WAS USED TO CHECK FOR A POSSIBLE PERICARDIAL EFFUSION. THE PATIENT'S BLOOD PRESSURE CONTINUED TO DROP AND ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED TO RESOLVE THE PATIENT'S CONDITION. ONCE THE PATIENT WAS STABILIZED, THE IMPLANT PROCEDURE WAS THEN COMPLETED SUCCESSFULLY AND THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0283

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R