BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1953536 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23642
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE RA LEAD REMAINS IMPLANTED AND A REPOSITIONING PROCEDURE HAS BEEN SCHEDULED. UPON FURTHER INFORMATION THIS PI WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    A PROCEDURE TOOK PLACE BUT THIS RA LEAD WAS NOT EXTRACTED THUS IT WAS CAPPED AND WILL NOT BE RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP LOSS OF CAPTURE WAS SEEN ON THE ATRIAL CHANNEL. IT WAS CONFIRMED BY X-RAY THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED. A REPOSITIONING PROCEDURE HAS BEEN SCHEDULED. 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