BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 4131661 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14158
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    August 11, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOWING RETURN AND COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) EXHIBITED LOSS OF CAPTURE AND WAS CONFIRMED DISLODGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND AS A RESULT THE LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC LEAD OF A DIFFERENT MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613115 FLEXTEND II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 0695| 4096| 4675| 7741| G179