BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 3181836 · Received June 14, 2013

    Report

    Report Number
    1000165971-2013-00296
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SORIN GROUP ITALIA 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): THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    UPON INTERROGATION ON (B)(6) 2013, THE PACEMAKER 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
    270967 REPLY NVZ SORIN GROUP ITALIA S.R.L. REPLY DR 2478

    Patients

    Seq Age Sex Outcome Treatment
    1