BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY 200

    MDR report key: 3784973 · Received February 7, 2014

    Report

    Report Number
    1000165971-2014-00064
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 24, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE US. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE US; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER P950029. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DEVICE PROGRAMMING ISSUES WERE REPORTEDLY ENCOUNTERED DURING THE IMPLANTATION PROCEDURE OF THIS PACEMAKER ON (B)(6)2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81105 REPLY 200 NVZ SORIN GROUP ITALIA S.R.L. REPLY 200 DR 272

    Patients

    Seq Age Sex Outcome Treatment
    1