BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2170085 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09867
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD FRACTURED. THE DEVICE WAS PROGRAMMED VOOR AT 75 AND A MAGNET WAS TAPED TO THE PATIENT. TECHNICAL SERVICES DISCUSSED THE MAGNET WOULD JUST CAUSE ASYNCHRONOUS PACING AT 100, WHICH THE CALLER DID CONFIRM, SO THERE WAS NO NEED FOR THE MAGNET. THE CALLER NOTED THEY WOULD DISCUSS FURTHER WHAT ACTIONS TO TAKE WITH THE PATIENT. THE PATIENT IS PACEMAKER DEPENDANT, HOWEVER NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR (B)(4)| (B)(4)| (B)(4)