BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3209466 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06752
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THAT THE HELIX WAS RETRACTED, DRIED BLOOD/BODY FLUID WAS NOTED IN THE HELIX MECHANISM UP THROUGH THE LUMEN AND A CUT IN THE LEAD LUMEN 260-268 MILLIMETERS FROM THE TERMINAL PIN. RESISTANCE TESTING AND A PRESSURE TEST OF THE INNER INSULATION WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. A PRESSURE TEST OF THE OUTER INSULATION WAS NOT PERFORMED DUE TO THE CUT IN THE INSULATION. THE LEAD DID NOT PASS THE HELIX MECHANISM TEST. THE HELIX FAILED TO EXTEND, MOST LIKELY DUE TO DRIED BLOOD/BODY FLUID IN THE MECHANISM. ANALYSIS WAS NOT ABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS BASED ON VISUAL AND ELECTRICAL TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS WHEN CONNECTED TO A PACING SYSTEM ANALYZER (PSA). THE LEAD WAS AN ATTEMPTED IMPLANT. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310230 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 4469| K173| 4087