BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 5179833 · Received October 27, 2015

    Report

    Report Number
    1000165971-2015-00636
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    October 1, 2015
    Report Date
    October 1, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    LWP
    PMA / PMN Number
    PP950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    UPON INTERROGATION OF THE PACEMAKER ON (B)(6) 2015, THE LANGUAGE WAS (B)(6) INSTEAD OF ENGLISH. MOREOVER, THE PACEMAKER WAS FOUND SWITCHED IN STAND-BY MODE. AS-SHIPPED SETTINGS WERE PROGRAMMED AFTER RE-INITIALIZATION OF THE PACEMAKER, EXCEPT FOR THE POLARITIES THAT WERE SET TO UNIPOLAR. REPORTEDLY, VENTRICULAR LEAD IMPEDANCE VALUE WAS ALSO FLUCTUATING. PRELIMINARY ANALYSIS SHOWED THAT THE PACEMAKER SWITCHED IN STANDBY MODE ON (B)(6) 2015, MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). THE PACEMAKER WAS PROPERLY REINITIALIZED ON (B)(6) 2015 AND ITS NORMAL FUNCTIONING WAS RESTORED. IT ALSO APPEARS THAT THE LANGUAGE OF THE PROGRAMMER SWITCHED TO GERMAN AFTER USING THE PACEART EXPORT FUNCTION.

    Description of Event or Problem · 1

    UPON INTERROGATION OF THE PACEMAKER ON (B)(6) 2015, THE LANGUAGE WAS (B)(6) INSTEAD OF ENGLISH. MOREOVER, THE PACEMAKER WAS FOUND SWITCHED IN STANDBY MODE. AS-SHIPPED SETTINGS WERE PROGRAMMED AFTER RE-INITIALIZATION OF THE PACEMAKER, EXCEPT FOR THE POLARITIES THAT WERE SET TO UNIPOLAR. REPORTEDLY, VENTRICULAR LEAD IMPEDANCE VALUE WAS ALSO FLUCTUATING. PRELIMINARY ANALYSIS SHOWED THAT THE PACEMAKER SWITCHED IN STANDBY MODE ON (B)(6) 2015, MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). THE PACEMAKER WAS PROPERLY REINITIALIZED ON (B)(6) 2015 AND ITS NORMAL FUNCTIONING WAS RESTORED. IT ALSO APPEARS THAT THE LANGUAGE OF THE PROGRAMMER SWITCHED TO GERMAN AFTER USING THE PACEART EXPORT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711430 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE LWP SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2404

    Patients

    Seq Age Sex Outcome Treatment
    1