BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2913734 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00105
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 25, 2012
    Report Date
    April 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PORTION OF LEAD WAS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT THE EXPLANTED PORTION OF LEAD WAS NOT GOING TO BE RETURNED FOR ANALYSIS. IT WAS BELIEVED TO HAVE BEEN INADVERTENTLY DISCARDED AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THREE DAYS POST-IMPLANT, THIS RIGHT ATRIAL (RA) LEAD WAS CONFIRMED VIA X-RAY TO BE DISLODGED. A REVISION PROCEDURE WAS PERFORMED. IT WAS REPORTED THAT DURING THE INCISION, THIS ATRIAL LEAD WAS INADVERTENTLY DAMAGED. THE DISTAL PORTION OF LEAD WAS REMOVED, AND THE TERMINAL PORTION OF THE LEAD WAS RETAINED TO PLUG THE ATRIAL PORT. NO NEW RA LEAD WAS IMPLANTED, AS THE ATRIAL PACING PERCENTAGE HAD BEEN VERY LOW. THE PATIENT HAD AN INTRINSIC RHYTHM, SO THE DUAL CHAMBER PACEMAKER REMAINED IMPLANTED TO PROVIDE BACKUP VVI PACING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20461 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R