BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1042368 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34267
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 10, 2008
    Report Date
    June 22, 2010
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NVN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL FIELD REPRESENTATIVE NOTIFIED THE FOLLOWING CLINIC OF THESE ALERTS. ACCORDING TO THE AVAILABLE INFORMATION, THIS CRT-D, RA LEAD, AND RV LEAD REMAIN IMPLANTED AND IN SERVICE. THE PHYSICIAN PLANS TO MONITOR THE SITUATION AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. ADDITIONAL INFORMATION INDICATES THAT THIS CRT-D WAS REPLACED WITH A COMPETITIVE DEVICE. DURING THE REPLACEMENT PROCEDURE, THE RA AND RV LEADS WERE REPORTEDLY TESTED VIA PACING SYSTEM ANALYZER (PSA) AND FOUND TO HAVE ACCEPTABLE MEASUREMENTS. WHEN ATTACHED TO THE REPLACEMENT DEVICE, LEAD MEASUREMENTS REMAINED WITHIN NORMAL RANGE. THE PHYSICIAN ELECTED TO LEAVE THESE CHRONIC LEADS IN SERVICE WITH THE NEW DEVICE. AN ATTEMPT IS BEING MADE TO RETRIEVE THE EXPLANTED DEVICE FOR RETURN AND ANALYSIS, BUT IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE RETURNED. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), TRANSVENOUS RIGHT ATRIAL (RA) LEAD, AND TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WERE MEASURING A HIGH RV AND RA PACING IMPEDANCE. THESE ISSUES, WHICH OCCURRED APPROXIMATELY 2 YEARS AGO, TRIGGERED LATITUDE RED AND YELLOW ALERTS, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CARDIAC PACEMAKERS, INC 4479 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6481 053439 WAS USED DURING THE EVENT.| THE DEVICE H175/312903 WAS IMPLANTED 16-MAR-2006| THE DEVICE 4518/316252 WAS IMPLANTED 16-MAR-2006| THE DEVICE 0148/151457 WAS IMPLANTED 16-MAR-2006