BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2992980 · Received March 1, 2013

    Report

    Report Number
    1000165971-2013-00109
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 18, 2013
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    THE PACEMAKER INVOLVED IN THIS COMPLAINT WAS INTERROGATED ON (B)(6) 2013, IN IT'S BOX AND IT WAS FOUND IN STANDBY MODE (BACKUP MODE). AN ANALYSIS IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88895 REPLY NVZ SORIN C.R.M., S.R.L. REPLY DR 2675

    Patients

    Seq Age Sex Outcome Treatment
    1