BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 2182854 · Received July 8, 2011

    Report

    Report Number
    9610579-2011-00073
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 4, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(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

    REPORTEDLY ON (B)(6) 2011 FOLLOW-UP, THE PHYSICIAN OBSERVED AT 9:30 AM THAT: THE DEVICE WAS IN STANDBY MODE. ABNORMAL BATTERY IMPEDANCE (14.12KOHMS) ALTHOUGH MAGNET RATE WAS NORMAL (96MIN-1). THE PHYSICIAN RE-INITIALIZED AND REPROGRAMMED THE DEVICE WITHOUT DIFFICULTIES. AT 10:16 AM, THE PHYSICIAN OBSERVED THAT: THE SENSING AND THRESHOLD TESTS AS WELL AS LEAD IMPEDANCES WERE NORMAL. THE BATTERY IMPEDANCE WAS NORMAL (1.07KOHMS). THE PHYSICIAN ASKED FOR AN EXPLANATION OF THE REPORTED BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S041015

    Patients

    Seq Age Sex Outcome Treatment
    1