BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2052725 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03701
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE TO OUR COMPANY, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PHYSICIAN BELIEVED THAT WHILE PLACING THE RIGHT VENTRICULAR LEAD, IT PERFORATED THE PATIENT. THE LEAD WAS SUCCESSFULLY PLACED, HOWEVER LATER THE PATIENT'S BLOOD PRESSURE DROPPED AND AN ECHOCARDIOGRAM CONFIRMED THERE WAS SOME BLOOD IN THE PERICARDIUM. THE PHYSICIAN NOTED THE PATIENT HAS A VERY THIN RIGHT VENTRICLE. THE PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT. THE PHYSICIAN'S PLAN WAS TO MONITOR THE PATIENT FOR NOW, THEN DO ANOTHER ECHOCARDIOGRAM TO SEE IF THE PATIENT STABILIZES OR NOT. THE PHYSICIAN NOTED THE PATIENT APPEARS STABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening