BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3905376 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11443
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE REVISION PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE OF THE SAME MODEL. ALL LEADS REMAINED IN USE WITH THE NEW DEVICE, AND ALL LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE. 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 THREE DAYS POST-IMPLANT, THIS RIGHT ATRIAL (RA) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 3,000 OHMS. PACING AND SENSING WERE APPROPRIATE. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE CHECKED THE DEVICE AND CONFIRMED THE OUT-OF-RANGE MEASUREMENTS. THE LEFT VENTRICULAR (LV) LEAD ALSO EXHIBITED OUT-OF-RANGE IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE (LOC) WAS NOTED; THE DEVICE WAS REPROGRAMMED TO PACE ONLY IN THE RIGHT VENTRICLE AND A REVISION PROCEDURE WAS PLANNED FOR THE FOLLOWING DAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383428 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0282| 4677| G179| 4480