BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1944730 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20004
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 8, 2010
    Report Date
    October 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS EXPLANTED, AND IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD HAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. DURING THE REVISION, IT WAS ALSO NOTED THE LEAD HAD PERFORATED INTO THE PATIENT'S PERICARDIUM. NO ADVERSE PATIENT EFFECTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention