BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 2202622 · Received August 8, 2011

    Report

    Report Number
    9610579-2011-00081
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, AFTER PROLONGED RESUSCITATION INCLUDING CARDIOVERSION AT HOME, PATIENT WAS HOSPITALIZED. TEMPORARY PACEMAKER WAS POSITIONED TO REPLACE THE MALFUNCTIONING PACEMAKER INVOLVED IN THIS MDR REPORT. AFTER INTENSIVE CARE, PATIENT DETERIORATED AND DIED 3 DAYS LATER. NO PATIENT FILES ARE AVAILABLE. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 M041118

    Patients

    Seq Age Sex Outcome Treatment
    1 Death