BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 4131771 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15304
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD NOTED SETSCREW MARKS WERE NOTED ON EACH TERMINAL PIN AND RING. THERE WAS ALSO BLOOD INFILTRATION NOTED IN THE HELIX HOUSING. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED SYNCOPE AND RETURNED TO THE HOSPITAL TEN DAYS POST-IMPLANT. ELECTROGRAMS REVEALED LOSS OF CAPTURE ON THE RV LEAD. INVESTIGATION PERFORMED BY THE CATHETER LAB DID NOT FIND ANY EVIDENCE THAT THE LEAD HAD DISLODGED. A LEAD REVISION WAS PERFORMED AND THE RV LEAD WAS TESTED ON THE PACING SYSTEM ANALYZER (PSA). BOTH THE PACING THRESHOLD AND IMPEDANCE MEASUREMENTS WERE FOUND TO BE INITIALLY HIGH WHEN THE LEAD WAS REPOSITIONED; HOWEVER, THE PACING IMPEDANCE MEASUREMENTS WERE NOTED TO BE OUT OF RANGE. THE RV LEAD WAS REPOSITIONED SEVERAL TIMES WITH THE SAME RESULT. THIS RV LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A NEW RV LEAD OF THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612941 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 4087| S208| 4088