BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2191004 · Received July 29, 2011

    Report

    Report Number
    1000165971-2011-00278
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 20, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, TWO DAYS AFTER IMPLANTATION THE IMPEDANCE DISPLAYED WAS > 1500 OHMS IN THE ATRIAL CHANNEL. THE ASSOCIATED LEAD AND SUBJECT PACEMAKER WERE SUBSEQUENTLY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2538

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention