BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 4140419 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17525
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    May 20, 2014
    Report Date
    September 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    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, VISUAL INSPECTION OF THE LEAD NOTED BOTH THE INTERNAL AND THE EXTERNAL INSULATION WAS ABRADED THROUGH TO THE CONDUCTOR COIL. MICROSCOPIC EVALUATION INDICATED THAT THE INSULATION DAMAGE WAS CAUSED BY LOCALIZED COMPRESSIVE STRESS ON THE INSULATION SURFACE. DUE TO THE LOCATION AND THE TYPE OF DAMAGE EXHIBITED, IT WAS CONCLUDED THAT THE DAMAGE WAS CAUSED BY LEAD ENTRAPMENT IN THE CLAVICLE-FIRST RIB REGION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. ALL LEAD MEASUREMENTS WERE NOTED TO BE ACCEPTABLE AND WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE PATIENT NOW HAD A NORMAL EJECTION FRACTION AND AN ELECTROPHYSIOLOGY STUDY WAS NEGATIVE. THE PATIENT ELECTED TO HAVE THE IMPLANTED SYSTEM EXPLANTED. THIS LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618275 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR E110| 0157| 4087