BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1893703 · Received November 9, 2010

    Report

    Report Number
    2124215-2010-21757
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    March 17, 2010
    Report Date
    August 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION REVEALED THE HELIX WAS EXTENDED. A CUT WAS NOTED IN THE SILICONE INSULATION. ANALYSIS REVEALED THE LEAD WAS ELECTRICALLY CONTINUOUS. THE HELIX FAILED TO RETRACT, LIKLEY DUE TO BLOOD IN THE HELIX MECHANISM. ELECTRICALLY, LEAD WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE DAY POST IMPLANT THIS ATRIAL LEAD WAS DISLODGED. A REVISION PROCEDURE WAS PERFORMED; THE LEAD WOULD NOT REMAIN IN POSITION. THIS LEAD WAS REMOVED AND REPLACED WITH A NON-BOSTON SCIENTIFIC CRM 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