BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 3211096 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07531
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. VISUAL INSPECTION NOTED A NICK IN THE OUTER INSULATION 26 AND 27CM FROM THE TERMINAL PIN. DRIED BLOOD WAS NOTED IN THE OUTER COIL 14-55.5CM FROM THE TERMINAL PIN, MOST LIKELY THROUGH THE NICKS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. A NEW RV LEAD WAS IMPLANTED WITH THE SAME HIGH IMPEDANCE MEASUREMENTS. THE NEW RV LEAD WAS REPOSITIONED AND THIS CORRECTED THE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309908 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1