BEUDAMED
    FDA Adverse Event Summary report: N

    SPRINT FIDELIS

    MDR report key: 1831043 · Received August 26, 2010

    Report

    Report Number
    1831043
    Date Received
    August 26, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 26, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED SEVERAL DAYS AGO WITH A DIAGNOSIS OF DISLODGED/DYSFUNCTIONAL LEFT VENTRICULAR (LV) PACING ELECTRODE, CONGESTIVE HEART FAILURE, DILATED NONISCHEMIC CARDIOMYOPATHY, ATRIAL FIBRILLATION AND MORBID OBESITY. THE CARDIOLOGY CONSULTATION NOTES: ANALYSIS OF HER DEVICE, AT THIS TIME SHOWED HIGH PACING THRESHOLDS WITHIN HER LV LEAD AND THE POSSIBILITY THAT THE LEAD WAS PERHAPS DISLODGED. THE PATIENT NEEDS OPERATIVE INTERVENTION WITH EVALUATION OF HER LEFT VENTRICULAR LEAD PHYSICALLY AND BY FLUOROSCOPY. THE PLAN WAS ALSO TO REMOVE THE SPRINT FIDELIS LEAD, AS IT WAS A RECALLED LEAD. THE PATIENT WENT TO THE OR TODAY. NOTES FROM THE OPERATIVE REPORT: FLUOROSCOPIC EXAMINATION OF THE PATIENT'S LEADS SHOWED SATISFACTORY POSITIONING OF THE RIGHT VENTRICULAR AND RIGHT ATRIAL PACING ELECTRODES. THE LEFT VENTRICULAR PACING ELECTRODE WAS LOCATED IN THE SUPERIOR VENA CAVA HAVING RETRACTED END OF THE HEART ENTIRELY. IT WAS CLEAR THAT THE PATIENT WILL NEED THIS LEAD REMOVED AND SINCE THE RIGHT VENTRICULAR (RV) LEAD WAS A RECALLED, MEDTRONIC SPRINT FIDELIS ELECTRODE; IT WAS DEEMED PRUDENT TO REMOVE IT AT THIS TIME. IT WAS REMOVED BY LASER LEAD EXTRACTION. THERE WERE NO COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS LEAD, DEFIBRILLATION LWS MEDTRONIC, INC. 6949 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR CARDIAC DRUGS