BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 1983879 · Received February 4, 2011

    Report

    Report Number
    9610579-2011-00009
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 20, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FEB 4, 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PACEMAKER INVOLVED IN THIS REPORT COULD NOT BE INTERROGATED UPON SCHEDULED FOLLOW UP. HOWEVER, NORMAL MAGNET OPERATION WAS OBSERVED. THIS BEHAVIOUR WAS OBSERVED DURING INTERROGATION ATTEMPTS PERFORMED ON (B)(6) 2011 AND (B)(6) 2011. THREE DIFFERENT PROGRAMMERS WERE USED, WITHOUT SUCCESS. ALL THE PROGRAMMING HEAD LEDS WERE ON (TELEMETRY INDICATOR); HOWEVER, THE MESSAGE "TELEMETRY ERROR: TRY REPOSITIONING THE HEAD." WAS DISPLAYED. THIS PT REPORTEDLY UNDERGONE A CT SCAN (ON THE ABDOMINAL AREA) IN (B)(6) 2010. THE DEVICE IS SCHEDULED TO BE EXPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S060916

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention