BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 3202212 · Received June 28, 2013

    Report

    Report Number
    1000165971-2013-00322
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SORINGROUP ITALIA 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)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A FOLLOW-UP PERFORMED ON (B)(6) 2013, THE ONSET OF THE RECORDED ATRIAL BURST EPISODE WAS NOT OBSERVED. AN EXPLANATION IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296135 REPLY NVZ SORINGROUP ITALIA S.R.L. REPLY DR 2386

    Patients

    Seq Age Sex Outcome Treatment
    1