BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT

    MDR report key: 2914985 · Received January 10, 2013

    Report

    Report Number
    1000165971-2013-00004
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    August 31, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    POLARITY PROGRAMMING ISSUES WERE REPORTED TO THE SUBJECT PACEMAKER. DURING A FOLLOW UP TWO DAYS POST IMPLANT CHECK ((B)(6) 2012), THE PHYSICIAN COULD NOT PROGRAM THE VENTRICULAR LEAD TO BIPOLAR. ON A FOLLOW-UP PERFORMED ON (B)(6) 2012, THE PACEMAKER DEPENDENT PATIENT REPORTED TO HIS/HER PHYSICIAN A BRIEF LOSS OF CONSCIOUSNESS DURING DAILY ACTIVITIES TWO WEEKS BEFORE. BIPOLAR PROGRAMMING WAS STILL NOT POSSIBLE, BUT ALL MEASUREMENTS WERE FINE (495 OHM, PACING THRESHOLD 0.8 V, AMPLITUDE 14.7 MV). THE PHYSICIAN ORDERED AN X-RAY OF THE PACING SYSTEM, IN WHICH THE VENTRICULAR LEAD SEEMS TO BE INCOMPLETELY INSERTED INTO THE HEADER. A PACEMAKER REVISION WAS PERFORMED ON THE NEXT DAY, BUT THE PHYSICIAN COULD NOT INSERT THE SCREWDRIVER COMPLETELY INSIDE THE SETSCREW CAVITY. A NEW PACEMAKER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15259 ESPRIT NVZ SORIN C.R.M., S.R.L. ESPRIT DR 2631

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention