BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 8141766 · Received December 7, 2018

    Report

    Report Number
    1000165971-2018-01048
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    November 5, 2018
    Report Date
    January 25, 2019
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT. - ATTACHMENT: [20190114 - FILE-2018-03740 - ANALYSIS_AND_CLOSURE_REPORT_RESP-2019-00042.PDF].

    Description of Event or Problem · 0

    THE PATIENT ATTENDED FOR ROUTINE YEARLY FOLLOW UP ON MONDAY AND WE WERE COMPLETELY UNABLE TO INTERROGATE THE DEVICE AT ALL. THE SCREEN DISPLAYED AS IF INTERROGATING BUT KEPT DISPLAYING THE 1ST ERROR MESSAGE (IMG 1477) DESPITE BEING FULLY OVER THE DEVICE WITH THE HEADER AND THE HEADER BEING FULL LIT, EVEN MOVEMENT OF THE HEADER INTO NUMEROUS POSITIONS DID NOT HELP. PACING WAS CONFIRMED VIA MAGNET AND ECG. AS THE DEVICE HAS BEEN IN SITU SINCE 2006 IT WAS DECIDED TO URGENTLY BOX CHANGE THIS PATIENT. DEVICE WAS EXPLANTED ON WEDNESDAY. DURING WHICH I MANAGED FINALLY AFTER 10 MINUTES TO BE ABLE TO INTERROGATE RANDOMLY, BATTERY WAS DISPLAYING 39 MONTHS AND ALL PARAMETERS OK. HOWEVER I WAS NOT ABLE TO REPROGRAM ANYTHING AS IT KEPT GIVING ME THE ERROR MESSAGE (IMG 1477) AND THEN ANOTHER ERROR MESSAGE (IMG 1478).

    Description of Event or Problem · 1

    THE PATIENT ATTENDED FOR ROUTINE YEARLY FOLLOW UP ON MONDAY AND WE WERE COMPLETELY UNABLE TO INTERROGATE THE DEVICE AT ALL. THE SCREEN DISPLAYED AS IF INTERROGATING BUT KEPT DISPLAYING THE 1ST ERROR MESSAGE (IMG 1477) DESPITE BEING FULLY OVER THE DEVICE WITH THE HEADER AND THE HEADER BEING FULL LIT, EVEN MOVEMENT OF THE HEADER INTO NUMEROUS POSITIONS DID NOT HELP. PACING WAS CONFIRMED VIA MAGNET AND ECG. AS THE DEVICE HAS BEEN IN SITU SINCE 2006 IT WAS DECIDED TO URGENTLY BOX CHANGE THIS PATIENT. DEVICE WAS EXPLANTED ON WEDNESDAY. DURING WHICH I MANAGED FINALLY AFTER 10 MINUTES TO BE ABLE TO INTERROGATE RANDOMLY, BATTERY WAS DISPLAYING 39 MONTHS AND ALL PARAMETERS OK. HOWEVER I WAS NOT ABLE TO REPROGRAM ANYTHING AS IT KEPT GIVING ME THE ERROR MESSAGE (IMG 1477) AND THEN ANOTHER ERROR MESSAGE (IMG 1478).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982232 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM RHAPSODY + DR 2530 S050512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention