BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 6547556 · Received May 5, 2017

    Report

    Report Number
    1000165971-2017-00376
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    March 27, 2017
    Report Date
    April 11, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    DXY
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEMAKER WAS FOUND IN STANDBY MODE AND REQUIRED RE-INITIALIZATION. 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) 2017 AND ITS NORMAL FUNCTIONING WAS RESTORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEMAKER WAS FOUND IN STANDBY MODE AND REQUIRED RE-INITIALIZATION. 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) 2017 AND ITS NORMAL FUNCTIONING WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329042 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE DXY SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2412

    Patients

    Seq Age Sex Outcome Treatment
    1