BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3904795 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10917
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE POST IMPLANT CHECK, ABNORMAL MEASUREMENTS WERE OBTAINED. THIS RIGHT VENTRICULAR LEAD AND DEVICE DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. IN ADDITION, NOISE AND INCREASED THRESHOLDS WERE OBSERVED. NO ASYSTOLE WAS OBSERVED. IT WAS THOUGHT THERE WAS A CONNECTION ISSUE. THERE WAS NO ASYSTOLE. A REVISION PROCEDURE IS INTENDED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS OBTAINED. A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THE CONNECTION WAS VERIFIED. IT WAS DETERMINED THAT THE ISSUE WAS DUE TO LEAD DISLODGEMENT. THIS LEAD WAS REPOSITIONED AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382294 FINELINE II IMPLANTABLE LEAD DTB GUIDANT PUERTO RICO BV 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R