BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 7272514 · Received February 15, 2018

    Report

    Report Number
    1000165971-2018-00178
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 18, 2018
    Report Date
    January 22, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 0

    REPORTEDLY, DURING A ROUTINE FOLLOW-UP, THE PACING MODE WAS FOUND CHANGED FROM VDD MODE TO VVI MODE. A MESSAGE REGARDING THE PACEMAKER RE-INITIALIZATION WAS DISPLAYED ON THE PROGRAMMER SCREEN. AFTER RE-INITIALIZATION, THE PACEMAKER WAS IN DDD MODE, THE PROGRAMMED BASIC RATE WAS 60 MIN-1 (MAX 120 MIN-1) AND THE POLARITY WAS UNIPOLAR. THE PARAMETERS WERE THEN REPROGRAMMED TO THEIR PREVIOUS VALUES. IT WAS CONSIDERED THAT THE PACEMAKER SWITCHED 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 RE-INITIALIZED DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2018 AND ITS NORMAL FUNCTIONING WAS RESTORED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A ROUTINE FOLLOW-UP, THE PACING MODE WAS FOUND CHANGED FROM VDD MODE TO VVI MODE. A MESSAGE REGARDING THE PACEMAKER RE-INITIALIZATION WAS DISPLAYED ON THE PROGRAMMER SCREEN. AFTER RE-INITIALIZATION, THE PACEMAKER WAS IN DDD MODE, THE PROGRAMMED BASIC RATE WAS 60 MIN-1 (MAX 120 MIN-1) AND THE POLARITY WAS UNIPOLAR. THE PARAMETERS WERE THEN REPROGRAMMED TO THEIR PREVIOUS VALUES. IT WAS CONSIDERED THAT THE PACEMAKER SWITCHED 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 RE-INITIALIZED DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2018 AND ITS NORMAL FUNCTIONING WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118068 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2551

    Patients

    Seq Age Sex Outcome Treatment
    1