BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT

    MDR report key: 3201581 · Received June 28, 2013

    Report

    Report Number
    1000165971-2013-00316
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SORIN GROUP ITALIA, 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

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2013, THE VENTRICULAR PACING IMPEDANCE MEASURED THROUGH SMARTCHECK (PROGRAMMER FEATURE) WAS ABOVE 3000 OHM AND THE VENTRICULAR PACING THRESHOLD COULD NOT BE MEASURED. PACING THRESHOLD AND IMPEDANCE TESTS WERE PERFORMED (WITHOUT SMARTCHECK FEATURE) AND NORMAL MEASUREMENT WERE OBTAINED AFTERWARDS. REVIEW OF THE RECORDED EPISODES LED TO A SUSPICION OF A LEAD ISSUE; IN ADDITION, THE V LEAD IMPEDANCE CURVE WAS NOT AVAILABLE. ACCORDING TO PRELIMINARY ANALYSIS RESULTS, VENTRICULAR LEAD ISSUE/LEAD CONNECTION ISSUE IS SUSPECTED. EVALUATION OF THE BENEFIT OF A RE-INTERVENTION HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295414 ESPRIT NVZ SORIN GROUP ITALIA, S.R.L. ESPRIT DR 2554

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention