BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2041818 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01216
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WILL BE RETURNED FOR ANALYSIS. UPON ANLAYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL DEVICE REPLACEMENT JUST BEFORE THE PROCEDURE A WARNING WAS NOTED. RIGHT ATRIAL (RA) LEAD IMPEDANCES APPEARED STABLE WHILE THE AMPLITUDES HAD DECREASED. DURING THE EXPLANT PROCEDURE OF THIS DEVICE THE RIGHT ATRIAL LEAD WAS PULLED OUT OF THE HEADER AND AT THE SAME TIME HAD BROKEN IN THE HANDS OF THE PHYSICIAN. INSULATION DAMAGE WAS NOTED. A PART OF THE LEAD WAS LEFT IN THE PATIENT AS THIS LEAD HAD BEEN IMPLANTED FOR A LONG PERIOD OF TIME AND THE PHYSICIAN FELT THAT EXTRACTING THE LEAD WOULD PUT THE PATIENT AT A GREATER RISK. THE PHYSICIAN BELIEVED THAT THE LEAD FRACTURE WAS DUE TO THE POSITION OF THE LEAD BENEATH THE DEVICE. ANOTHER RIGHT ATRIAL LEAD WAS NOT IMPLANTED, WHILE THE DEVICE REPLACEMENT PROCEDURE WAS FINISHED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 0158| 4470| 1871