BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1874852 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17879
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS REMOVED, REPLACED AND DISCARDED. NO RETURN OF PRODUCT IS INTENDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE MONTH POST IMPLANT, THIS ATRIAL LEAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE. LEAD DISLODGEMENT WAS SUSPECTED. A REVISION PROCEDURE WAS PERFORMED, ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL. THE LEAD WAS REMOVED AND REPLACED. NO LOSS OF THERAPY OCCURRED. THERE WAS NO ALLEGATION AGAINST THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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