BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1951916 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23099
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    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

    AT THIS TIME, THIS RA LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, A WARNING SCREEN WAS DISPLAYED THAT A AUTOMATIC LEAD SAFETY SWITCH HAD OCCURRED WITH THE DEVICE. FURTHER INVESTIGATION REVEALED A PACING IMPEDANCE MEASUREMENT ABOVE 2500 OHMS ON THE RIGHT ATRIAL (RA) LEAD. IN ADDITION, THERE WAS LOSS OF CAPTURE AT MAXIMUM OUTPUTS AND A REVIEW OF THE DAILY MEASUREMENTS SHOWED A SIGNIFICANT INCREASE IN PACING IMPEDANCE MEASUREMENTS ON THE RA LEAD SINCE SEPTEMBER. THE RIGHT VENTRICULAR LEAD HAD NORMAL MEASUREMENTS. A FRACTURE OF THIS RA LEAD IS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE PATIENT STATED THAT NO SYMPTOMS WERE EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other 1291| 4470| 4457