BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCHESTRA

    MDR report key: 6416619 · Received March 20, 2017

    Report

    Report Number
    1000165971-2017-00225
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 20, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    DXY
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS SHOWED THAT THE DISPLAYED EGM WAS MOST PROBABLY CHANGED MANUALLY BY THE USER FROM EGM A TO EGM V BEFORE LAUNCHING THE ATRIAL THRESHOLD TEST. THE DISPLAYED CHANNEL REMAINS THE ONE MANUALLY SELECTED BY THE USER, AS EXPECTED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A PACEMAKER FOLLOW-UP PERFORMED ON (B)(6) 2017, IT WAS OBSERVED THAT WHEN ¿A LEAD¿ WAS SELECTED FOR THRESHOLD TESTING, THE DISPLAYED EGM DID NOT AUTOMATICALLY CHANGE FROM EGM V TO EGM A. AFTERWARDS, THE OPERATOR MANUALLY HAD EGM A DISPLAYED AND STARTED A THRESHOLD TEST AGAIN. ATRIAL THRESHOLD TESTING WAS THEN SUCCESSFULLY PERFORMED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A PACEMAKER FOLLOW-UP PERFORMED ON (B)(6) 2017, IT WAS OBSERVED THAT WHEN ¿A LEAD¿ WAS SELECTED FOR THRESHOLD TESTING, THE DISPLAYED EGM DID NOT AUTOMATICALLY CHANGE FROM EGM V TO EGM A. AFTERWARDS, THE OPERATOR MANUALLY HAD EGM A DISPLAYED AND STARTED A THRESHOLD TEST AGAIN. ATRIAL THRESHOLD TESTING WAS THEN SUCCESSFULLY PERFORMED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A PACEMAKER FOLLOW-UP PERFORMED ON (B)(6) 2017, IT WAS OBSERVED THAT WHEN ¿A LEAD¿ WAS SELECTED FOR THRESHOLD TESTING, THE DISPLAYED EGM DID NOT AUTOMATICALLY CHANGE FROM EGM V TO EGM A. AFTERWARDS, THE OPERATOR MANUALLY HAD EGM A DISPLAYED AND STARTED A THRESHOLD TEST AGAIN. ATRIAL THRESHOLD TESTING WAS THEN SUCCESSFULLY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199066 ORCHESTRA PROGRAMMER, PACEMAKER DXY SORIN GROUP ITALIA S.R.L. - CRM FACILITY ORCHESTRA PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1