BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 5665994 · Received May 19, 2016

    Report

    Report Number
    1000165971-2016-00295
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    April 11, 2016
    Report Date
    April 22, 2016
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT FOR COMPLETE DETAILS.

    Description of Event or Problem · 1

    UPON INTERROGATION DURING THE FOLLOW-UP OF (B)(6) 2016, THE DEVICE WAS FOUND IN STANDBY MODE. PRELIMINARY ANALYSIS RESULTS CONFIRMED THE REPORTED SWITCH IN STANDBY MODE. IT WAS MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). THE DEVICE WAS PROPERLY REINITIALIZED DURING THE FOLLOW-UP OF (B)(6) 2016 AND ITS NORMAL FUNCTIONING WAS RESTORED.

    Description of Event or Problem · 1

    UPON INTERROGATION DURING THE FOLLOW-UP OF (B)(6) 2016, THE DEVICE WAS FOUND IN STANDBY MODE.PRELIMINARY ANALYSIS RESULTS CONFIRMED THE REPORTED SWITCH IN STANDBY MODE, WHICH OCCURRED ON (B)(6) 2016. IT WAS MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). THE DEVICE WAS PROPERLY REINITIALIZED DURING THE FOLLOW-UP OF (B)(6) 2016 AND ITS NORMAL FUNCTIONING WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323359 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2689

    Patients

    Seq Age Sex Outcome Treatment
    1