BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2163506 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07444
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RIGHT ATRIAL (RA) LEAD WERE EXHIBITING HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THERE WAS ALSO BASELINE NOISE ON THE RA CHANNEL THAT RESULTED IN A SMALL AMOUNT OF OVERSENSING. AN ATRIAL THRESHOLD TEST WAS PERFORMED IN AAI MODE WHICH PRODUCED APPROPRIATE THRESHOLD MEASUREMENTS. AFTER THE TEST, THE BASELINE NOISE RESOLVED. A MANUAL LEAD IMPEDANCE TEST WAS PERFORMED WHICH REPORTED NORMAL VALUES AROUND 700 OHMS. ATTEMPTS TO REPRODUCE THE OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE UNSUCCESSFUL. THE PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION. THE PHYSICIAN REPROGRAMMED THE DEVICE TO VVIR MODE. THERE WERE NO ADDITIONAL PLANS FOR INTERVENTION. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4469| 0158| T125| E110