BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2151527 · Received June 24, 2011

    Report

    Report Number
    1000165971-2011-00226
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 1, 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 UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) AND (B)(6) 2011 FOLLOW-UP, THE PHYSICIAN OBSERVED THAT THE STATISTIC DATA CORRESPONDING TO THE NIGHT AND DAY DISTRIBUTIONS OF THE OCCURRENCES OF AV BLOCKS WERE INCONSISTENT. THE PHYSICIAN REQUESTED AN EXPLANATION OF THE REPORTED BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2509

    Patients

    Seq Age Sex Outcome Treatment
    1