BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 1871896 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17311
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 26, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PROCEDURE TO REPOSITION THE LEAD WAS SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED. LOSS OF RA CAPTURE WAS ALSO NOTED DUE TO THE DISLODGEMENT. 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