BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2153566 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06573
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAD DISLODGEMENT DID NOT RESULT IN ASYSTOLE OR LOSS OF CAPTURE. THE LEAD WAS EXPLANTED AND THE RIGHT ATRIAL PORT WAS PLUGGED. THERE WERE NO FURTHER PATIENT EFFECTS.

    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 RECIEVED INFORMATION THAT SHORTLY AFTER THE IMPLANT OF THE DEVICE AND LEAD SYSTEM, THE PATIENT PRESENTED WITH PAIN, SHORTNESS OF BREATH AND A DECREASE IN BLOOD PRESSURE. IT WAS CONFIRMED THAT THE RIGHT ATRIAL LEAD HAD DISLODGED AND A PERFORATION WAS SUSPECTED. AN ECHOCARDIOGRAPHY CONFIRMED A HEMATOMA. A LEAD REPOSITIONING PROCEDURE WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4095

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O