BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 6011510 · Received October 7, 2016

    Report

    Report Number
    1000165971-2016-00619
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 15, 2016
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STANDARD FOLLOW-UP, THE MESSAGE ¿INTERROGATION IS STOPPED, OK¿ IS DISPLAYED DURING THE INTERROGATION. BY PRESSING ¿OK¿, THE PHYSICIAN OBSERVED THAT THE RECOMMEND REPLACEMENT TIME WAS MISSING. DESPITE INTERROGATING THE DEVICE SEVERAL TIMES, THE SAME MESSAGE WAS DISPLAYED. THE PHYSICIAN STATED THAT OTHER THAN THE MISSING TIME TO REPLACEMENT INFORMATION, THE DEVICE OPERATED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663936 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY SR 2250 S090303

    Patients

    Seq Age Sex Outcome Treatment
    1