BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2151584 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06055
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 26, 2011
    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

    UPON RETURN TO OUR QUALITY ASSURANCE LABORATORY THIS LEAD UNDERWENT DETAILED ANALYSIS. VISUAL INSPECTION NOTED THE HELIX WAS RETRACTED AND INTACT WITH DRIED BLOOD IN THE HOUSING AND LUMEN. THE LEAD MET ELECTRICAL SPECIFICATIONS. IN CONCLUSION, LAB ANALYSIS COULD NOT CONFIRM THE ALLEGATION OF DISLODGEMENT. HOWEVER, ANALYSIS CONFIRMED THE HELIX ALLEGATION FAILURE WHICH WAS MOST LIKELY DUE TO THE BLOOD IN THE MECHANISM.

    Additional Manufacturer Narrative · 1

    THE REPRESENTATIVE REPORTED THE LEAD WAS TO BE RETURNED. INVESTIGATION IS COMPLETE TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD HAD DISLODGED INTO THE PATIENT'S POCKET. THIS WAS DISCOVERED THROUGH SENSING ISSUES AND LATER CONFIRMED BY X-RAY. THE PATIENT HAD NO SYMPTOMS AS A RESULT AS THE PATIENT WAS IN ATRIAL FIBRILLATION. THE LEAD WAS ATTEMPTED TO BE REVISED HOWEVER THE HELIX MECHANISM NO LONGER WORKED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 4087| 4554| N119| 0185