BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3210342 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08896
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS LEAD WAS NOT EXPLANTED BUT RATHER WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD WAS FOUND TO HAVE SEPARATED FROM THE DISTAL PORTION OF THE LEAD BODY. THIS LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310777 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 4135| 1280| 4479| 4457| K063