BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 1952334 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24321
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE OUT PROCEDURE A SUDDEN DECREASE IN RIGHT ATRIAL (RA) LEAD IMPEDANCES WAS NOTED AS WELL AS AN INCREASE IN THRESHOLDS. A MICRO-DISLODGEMENT WAS SUSPECTED. THE RA LEAD WAS CAPPED AND A NEW RA LEAD WAS IMPLANTED. 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 (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)