BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT

    MDR report key: 3133615 · Received May 24, 2013

    Report

    Report Number
    1000165971-2013-00270
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF THE SUBJECT DEVICE, THE VENTRICULAR LEAD IMPEDANCE MEASURED BY THE DEVICE WAS >2000OHMS. A RE-INTERVENTION WAS PERFORMED AND THE LEAD APPEARED TO BE LOOSE IN THE HEADER, WHILE LEAD MEASUREMENTS WERE SATISFACTORY. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231803 ESPRIT NVZ SORIN GROUP ITALIA S.R.L. ESPRIT DR 2653

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention