BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3210340 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08410
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS AND COMPLETE LOSS OF CAPTURE DUE TO A FRACTURE. NOISE WAS ALSO NOTED ON THE LEAD WHICH WAS OVERSENSED AND RESULTED IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. ATRIAL PACING INHIBITION OF APPROXIMATELY EIGHT SECONDS WAS NOTED IN ONE OF THE EPISODES. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309601 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 4470| 4525| N118| 1861| H173| 0147