BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2053207 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04976
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 23, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE HELIX MECHANISM WAS EXTENDED AND UNABLE TO BE RETRACTED, MOST LIKELY DUE TO DRIED BODY FLUID IN THE MECHANISM. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE LEAD'S ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REVEAL ANY ABNORMALITIES WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED LOSS OF CAPTURE AS THE LEAD TESTED ELECTRICALLY CONTINUOUS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED LOSS OF CAPTURE AND A REDUCTION IN SENSING. ONE MONTH POST IMPLANT, THE LEAD WAS EXPLANTED AND REPLACED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE LOSS OF CAPTURE OR THE EXPLANT PROCEDURE.

    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 82 YR Hospitalization| L| R 4470| S603| 4088