BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1951053 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23616
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICE WAS PROGRAMMED TO THE MAXIMUM OUTPUT FOR THE ATRIAL LEAD AND A CHEST X-RAY WAS BEING CONSIDERED TO DETERMINE THE LEAD POSITION. AT THIS TIME, THIS RA LEAD REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AND NO SURGICAL INTERVENTION HAS BEEN PLANNED. 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 PATIENT FOLLOW UP, THIS RIGHT ATRIAL (RA) LEAD PRESENTED WITH INTERMITTENT LOSS OF CAPTURE. NO CAPTURE WHEN THE LEAD WAS IN BIPOLAR MODE BUT CAPTURE AT HIGH OUTPUTS IN UNIPOLAR MODE. IT WAS SUSPECTED THAT THE LEAD HAD DISLODGED. 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 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 Other