BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3905710 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11371
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    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 THE IMPLANT PROCEDURE, THIS PACEMAKER AND ASSOCIATED RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS. THE LEAD WAS TESTED IN THE UNIPOLAR CONFIGURATION AND THE IMPEDANCE REMAINED LESS THAN 200 OHMS. THE LEAD WAS TESTED ON THE PACING SYSTEM ANALYZER (PSA) AND THE IMPEDANCE MEASUREMENT WAS 500 OHMS. A NEW DEVICE OF THE SAME MODEL WAS CONNECTED TO THE RV LEAD AND THE PACING IMPEDANCE MEASUREMENT WAS 550 OHMS. THIS RV LEAD AND THE SECOND PACEMAKER REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384058 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 4470| K287| 4471