BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE I

    MDR report key: 2052734 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03985
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 26, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS RA LEAD REMAINED IMPLANTED. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT ATRIAL LEAD HAD EXHIBITED NOISE DURING THE RIGHT VENTRICULAR (RV) LEAD INTERVENTION THAT WAS PERFORMED. IT WAS VISUALLY OBSERVED THAT THIS RA LEAD WAS CRUSHED/BENT BACK ON ITSELF WHEN CONNECTED TO THE NEW DEVICE THAT WAS BEING IMPLANTED AT THIS TIME AS WELL. THERE HAD BEEN NO INDICATION OF AN ATRIAL LEAD ISSUE PRIOR TO OPENING THE POCKET. THE IMPLANTING PHYSICIAN DECIDED NOT TO REPLACE THE ATRIAL LEAD, AND THE NEW DEVICE WAS REPROGRAMMED TO VVI. THE LOCAL AREA SALES REPRESENTATIVE CONFIRMED THAT THERE HAD BEEN NO ASYSTOLE OR SYNCOPE AS A RESULT OF THE VARIOUS PRODUCT PERFORMANCE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE I IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4461

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention 0144| 1851| T127| 4461