BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 3852888 · Received June 6, 2014

    Report

    Report Number
    1000165971-2014-00317
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, PATIENT RETURNED FOR A ROUTINE FOLLOW-UP BUT THE DEVICE COULD NOT BE INTERROGATED BY 2 DIFFERENT PROGRAMMERS (MESSAGE "INTERROGATION IS STOPPED¿ POPPED UP). MAGNET WAS PLACED ON THE DEVICE AND THE RATE WAS SHOWN TO BE 80MIN-1 WITH GOOD CAPTURE TEST AS WELL. CLINIC IS CONCERNED WHY THE SYMPHONY FLIPPED TO ELECTIVE REPLACEMENT INDICATOR SO SOON WHEN GOOD BATTERY CELL IMPEDANCE WAS SEEN AT LAST FOLLOW-UP (0.69 KOHMS A YEAR AGO). IT WAS POSSIBLE TO PROGRAM THE DEVICE TO NOMINAL MODE VIA TELEMETRY HEAD BUTTON, BUT STILL COULD NOT INTERROGATE THE DEVICE (SAME MESSAGE KEPT POPPING UP). THE PHYSICIAN DECIDED TO CHANGE THE DEVICE THAT WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, PATIENT RETURNED FOR A ROUTINE FOLLOW-UP BUT THE DEVICE COULD NOT BE INTERROGATED BY 2 DIFFERENT PROGRAMMERS (MESSAGE "INTERROGATION IS STOPPED" POPPED UP). MAGNET WAS PLACED ON THE DEVICE AND THE RATE WAS SHOWN TO BE 80MIN-1 WITH GOOD CAPTURE TEST AS WELL. CLINIC IS CONCERNED WHY THE SYMPHONY FLIPPED TO ELECTIVE REPLACEMENT INDICATOR SO SOON WHEN GOOD BATTERY CELL IMPEDANCE WAS SEEN AT LAST FOLLOW-UP (0.69 KOHMS A YEAR AGO). IT WAS POSSIBLE TO PROGRAM THE DEVICE TO NOMINAL MODE VIA TELEMETRY HEAD BUTTON, BUT STILL COULD NOT INTERROGATE THE DEVICE (SAME MESSAGE KEPT POPPING UP). THE PHYSICIAN DECIDED TO CHANGE THE DEVICE THAT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331212 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY SR 2250 M061114

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention