BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2153094 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06354
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE OF THIS RIGHT ATRIAL (RA) LEAD AND SEVERAL REPOSITIONING ATTEMPTS A PERICARDIAL EFFUSION WAS NOTED. THE PHYSICIAN SUSPECTED THAT THE EFFUSION WAS THE RESULT OF A PERFORATION BY THE RIGHT ATRIAL LEAD. THE LEAD WAS LEFT IMPLANT, BUT AN INCREASE IN THRESHOLDS WAS NOTED. ALL OTHER MEASUREMENTS WERE STABLE. THE IMPLANT PROCEDURE WAS COMPLETED WITH NO FURTHER ADVERSE PATIENT EFFECTS.

    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 Other