BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 3954820 · Received July 24, 2014

    Report

    Report Number
    1000165971-2014-00421
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    April 16, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A FOLLOW-UP, THE SUBJECT PACEMAKER WAS REPORTEDLY FOUND IN DDD PACING MODE / UNIPOLAR, WHEREAS IT HAD BEEN PREVIOUSLY IN SAFER MODE / BIPOLAR. THE FOLLOW-UP COULD BE COMPLETED AND THE PARAMETERS WERE REPROGRAMMED TO SAFER / BIPOLAR (IN (B)(6) 2014). UPON NEXT FOLLOW UP, THE PARAMETERS REMAINED IN SAFER / BIPOLAR AS PROGRAMMED. THE REPORTER REQUESTED AN EXPLANATION. PRELIMINARY ANALYSIS REVEALED THAT THE PACEMAKER WAS FOUND IN STANDBY MODE (I.E. BACKUP MODE) AND WAS RE-INITIALIZED UPON THE INTERROGATION PERFORMED ON (B)(6) 2014.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP, THE SUBJECT PACEMAKER WAS REPORTEDLY FOUND IN DDD PACING MODE / UNIPOLAR, WHEREAS IT HAD BEEN PREVIOUSLY IN SAFER MODE / BIPOLAR. THE FOLLOW-UP COULD BE COMPLETED AND THE PARAMETERS WERE REPROGRAMMED TO SAFER / BIPOLAR (IN (B)(6) 2014). UPON NEXT FOLLOW UP, THE PARAMETERS REMAINED IN SAFER / BIPOLAR AS PROGRAMMED. THE REPORTER REQUESTED AN EXPLANATION. PRELIMINARY ANALYSIS REVEALED THAT THE PACEMAKER WAS FOUND IN STANDBY MODE (I.E. BACKUP MODE) AND WAS RE-INITIALIZED UPON THE INTERROGATION PERFORMED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433178 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY DR 2550

    Patients

    Seq Age Sex Outcome Treatment
    1