BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 3315834 · Received August 23, 2013

    Report

    Report Number
    9610579-2013-00066
    Event Type
    Injury
    Date Received
    August 23, 2013
    Date of Event
    July 31, 2013
    Report Date
    July 31, 2013
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. METHOD - THE PROGRAMMER FILES WERE REVIEWED. THE REPORTED EVENT RESULTED FROM A DATA ALTERATION MOST PROBABLY CAUSED BY A SEU. THE DEVICE RE-INITIALIZATION RESTORED NORMAL BEHAVIOR. THERE IS NO FURTHER INDICATION FOR THE SUBJECT DEVICE; NORMAL FOLLOW-UP INTERVALS (AS RECOMMENDED IN THE LABELING) SHOULD BE APPLIED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A FOLLOW-UP PERFORMED ON (B)(6) 2013, THE PATIENT REPORTED FEELING PALPITATIONS SINCE ROUGHLY ONE MONTH. THE DEVICE COULD NOT BE INTERROGATED AND PACING AT 96 MIN-1 WAS OBSERVED WITH OR WITHOUT MAGNET APPLICATION. ON (B)(6) 2013, PATIENT WAS SEEN AGAIN. THE DEVICE WAS FORCED TO SWITCH TO STANDBY MODE AND A SERVICE COMPLETE RE-INITIALIZATION WAS PERFORMED AFTERWARDS SUCCESSFULLY. THE DEVICE COULD BE INTERROGATED AND PROGRAMMED AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413226 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S070104

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention