BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2163138 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07442
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 DURING A NORMAL DEVICE UPGRADE PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD WAS FOUND TO BE DISLODGED. THE LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED. 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 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR MISMATCH| 4480| 4136| 4554| N119| 0138| T180