BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3122247 · Received May 17, 2013

    Report

    Report Number
    1000165971-2013-00248
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 25, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    REPORTEDLY, ON (B)(6) 2013, ABNORMALLY HIGH VENTRICULAR LEAD IMPEDANCE WAS MEASURED, ASSOCIATED WITH V CAPTURE FAILURE. ON (B)(6) 2013, A RE-INTERVENTION WAS PERFORMED AND THE V LEAD WAS FOUND LOOSE (IT CAME OUT OF THE PORT WITHOUT UNSCREWING THE SETSCREW). IT WAS SUCCESSFULLY TESTED AND RECONNECTED TO THE PACEMAKER. THE SAME LEADS AND PACEMAKER REMAIN IMPLANTED. PRELIMINARY ANALYSIS OF FOLLOW-UP DATA CONFIRMED THAT ABNORMALLY HIGH (ABOVE 3000 OHMS) VENTRICULAR LEAD IMPEDANCE WAS MEASURED BETWEEN (B)(6) 2013. NEVERTHELESS, THE REPORTED V CAPTURE FAILURE WAS NOT OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219107 REPLY NVZ SORIN GROUP ITALIA S.R.L. REPLY DR 2579

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention