BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2182696 · Received July 8, 2011

    Report

    Report Number
    1000165971-2011-00251
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 4, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE U.S. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2011, THE PHYSICIAN OBSERVED A PACING INTERVAL OF 1078MS ON THE EPISODE DATED (B)(6) 2010 14:40. THE PHYSICIAN ASKED WHY SUCH PACING INTERVAL WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2450

    Patients

    Seq Age Sex Outcome Treatment
    1