BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND II

    MDR report key: 3212381 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08506
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS RETURNED AND TESTED. THE HELIX MECHANISM WAS NOTED TO HAVE BEEN STUCK, MOST LIKELY DUE TO BLOOD/BLOOD FLUID INFILTRATION. IT WAS ALSO NOTED THAT THE CATHODE CONDUCTOR COIL WAS FRACTURED AT THE DISTAL END OF THE TERMINAL PIN. LABORATORY ANALYSIS CONCLUDED THAT THE FRACTURE WAS MOST LIKELY DUE TO OVER-TORQUE APPLIED TO THE TERMINAL PIN TO ACTUATE THE HELIX.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS RIGHT VENTRICULAR LEAD IT WAS NOT POSSIBLE TO FIXATE THE LEAD INTO THE HEART AND THE HELIX DID NOT WORK PROPERLY. THE LEAD WAS PLACED ON THE SURGICAL TABLE AND THE HELIX WAS MANIPULATED BUT WAS NOTED TO NOT EXTEND OR RETRACT. A NEW LEAD WAS USED. THIS RIGHT VENTRICULAR LEAD WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313888 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1