BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1771651 · Received July 28, 2010

    Report

    Report Number
    2124215-2010-12203
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 4, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS EXHIBITING INTERMITTENT LOSS OF CAPTURE. THERE WAS NO CHANGE IN IMPEDANCE MEASUREMENTS; HOWEVER, THE PHYSICIAN WAS CONVINCED THAT THE LEAD WAS FRACTURED. THEREFORE, A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR S606| 4087| 1280| 4088