BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3913523 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-09355
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING IMPLANT PROCEDURE WHILE REPOSITIONING THIS RIGHT ATRIAL (RA) LEAD, A PHYSICIAN HAD DIFFICULTIES INSERTING THE STYLET INTO THIS LEAD. THIS RA LEAD WAS BEING REPOSITIONED TO OBTAIN BETTER MEASUREMENTS. FURTHER, A LEAD CONDUCTOR FRACTURE OCCURED. THIS RA LEAD WAS NEVER IN SERVICE AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391832 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 4480