BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2913123 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16677
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED AND IN USE. NO FURTHER INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT ATRIAL (RA) LEAD WAS SEEN IN THE CLINIC AFTER A REPORTED EPISODE. NO DETAILS WERE AVAILABLE REGARDING THE EPISODE. HOWEVER, DEVICE INTERROGATION SHOWED LEAD MEASUREMENTS WERE GOOD AND WITHIN NORMAL LIMITS. AN X-RAY WAS PERFORMED AND IT WAS REVEALED THAT THE RA LEAD WAS DISLODGED. NO CHANGES WERE MADE TO THE SYSTEM PROGRAMMING, AND NO LEAD REVISION WAS PLANNED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20847 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 4457| 4480| S602