BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 1930064 · Received November 18, 2010

    Report

    Report Number
    9610579-2010-00618
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 9, 2010
    Report Date
    November 5, 2010
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2010, THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE US; HOWEVER, IT IS SIMILAR TO SYMPHONY DR MODELS APPROVED UNDER (B)(4). ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PT IMPLANTED WITH THE SYMPHONY D (B)(4) PACEMAKER INVOLVED IN THIS MDR REPORT WAS STRUCK BY LIGHTNING IN (B)(6) 2010. THE PT, WHO IS NOT PACEMAKER DEPENDENT, WAITED TO BE ON CARDIAC DECOMPENSATION BEFORE VISITING THE PHYSICIAN ON (B)(6), 2010. DURING THAT F/U, THE PACEMAKER WAS FOUND IN STANDBY MODE AND REINITIALIZED IT WITHOUT DIFFICULTIES. THE PHYSICIAN REQUESTED A CONFIRMATION RELATED TO THE RIGHT REINITIALIZATION AND FOR RECOMMENDATIONS FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY D 2450 S060502

    Patients

    Seq Age Sex Outcome Treatment
    1