BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3210115 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06191
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    NOTAPVD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN SERVICE AND THEREFORE; WILL NOT BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT, THIS RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED; AND THE LEADS WERE SUCCESSFULLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310465 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R