BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2915527 · Received January 10, 2013

    Report

    Report Number
    1000165971-2013-00008
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PACEMAKER INVOLVED IN THIS COMPLAINT WAS INTERROGATED ON (B)(6) 2012 AND IT WAS FOUND IN STANDBY MODE (BACKUP MODE). IT WAS THEN AUTOMATICALLY RE-INITIALIZED BY THE PROGRAMMER. AN ANALYSIS IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15051 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2374

    Patients

    Seq Age Sex Outcome Treatment
    1