BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 2253327 · Received September 19, 2011

    Report

    Report Number
    2124215-2011-15912
    Event Type
    Death
    Date Received
    September 19, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 31, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RV LEAD WILL NOT BE RETURNED FOR LABORATORY ANALYSIS. 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 IMPLANTATION OF THIS RIGHT VENTRICULAR (RV) LEAD, THE PATIENT'S BLOOD PRESSURE DROPPED. ALTHOUGH NO PERFORATION WAS OBSERVED ON THE X-RAY, THE PHYSICIAN BEGAN PERICARDIAL ASPIRATION ASSUMING A PERFORATION HAD OCCURRED. ALL ATTEMPTS TO STABILIZE THE PATIENT WERE UNSUCCESSFUL AND THE PATIENT SUBSEQUENTLY DIED FROM CARDIAC TAMPONADE. THERE WERE NO ALLEGATIONS MADE AGAINST THE FUNCTIONALITY OF THE RV LEAD. THE PHYSICIAN ALSO REPORTED THAT THIS PATIENT HAD SUFFERED A MYOCARDIAL INFARCTION (B)(6) PRIOR AND THE MYOCARDIUM IN THE VENTRICLE WAS WEAKENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Death