BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3043110 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01615
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    NOTAPVD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING PRODUCT RETURN AND COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS LEAD WAS THOROUGHLY ANALYZED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, LOSS OF CAPTURE AND AN ABSENCE OF BRADY PACING, WERE EXHIBITED WITH THIS NEWLY IMPLANTED SYSTEM. THE DAY FOLLOWING THIS OBSERVATION, THE DEVICE AND ASSOCIATED RIGHT VENTRICULAR LEAD, WERE SUCCESSFULLY REMOVED FROM SERVICE AND A COMPETITOR SYSTEM IMPLANTED. BOTH EXPLANTED PRODUCTS ARE INTENDED TO BE RETURNED FOR A POST MARKET EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146171 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R