BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT

    MDR report key: 1930071 · Received November 18, 2010

    Report

    Report Number
    1000165971-2010-00979
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 27, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S., HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER (B)(4). ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE ESPRIT S PACEMAKER INVOLVED IN THIS MDR REPORT WAS IMPLANTED ON (B)(6), 2010 WITHOUT ANY DIFFICULTY. AFTER IMPLANTATION, THE PATIENT WENT SEVERAL TIMES BACK TO THE HOSPITAL IN EMERGENCY DUE TO DIZZINESS; HOWEVER, NORMAL PACEMAKER OPERATION WAS OBSERVED. ON (B)(6), THE PATIENT CAME BACK AGAIN TO THE HOSPITAL IN EMERGENCY WITH A HEAD TRAUMA AFTER A SYNCOPE. THE PHYSICIAN MONITORED THE DEVICE WITH SURFACE ECG AND ABRUPT CHANGES IN PACING RATE WERE OBSERVED: SUDDEN CHANGES FROM 70 MIN-1 TO A SLOW RATE (42 MIN-1 AND 33 MIN-1) AND VERY FAST RATE (128 MIN-1). A NORMAL LEAD IMPEDANCE WAS MEASURED AND CAPTURE WAS CONFIRMED. DUE TO THESE UNEXPECTED BEHAVIORS, THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. ANOTHER ESPRIT S PACEMAKER WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT NVZ SORIN BIOMEDICA C.R.M., S.R.L. ESPRIT S 2454

    Patients

    Seq Age Sex Outcome Treatment
    1