BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 2050802 · Received April 1, 2011

    Report

    Report Number
    9610579-2011-00026
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 24, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE PHYSICIAN OBSERVED THAT THE ELECTIVE REPLACEMENT INDICATOR WAS REACHED (BATTERY IMPEDANCE GREATER THAN 10 KOHM). HOWEVER ON (B)(6) 2010 FOLLOW-UP (ONE YEAR AGO), THE BATTERY IMPEDANCE WAS 2.5 KOHM AND THE ESTIMATED LONGEVITY WAS 58 MONTHS; THEREFORE PREMATURE BATTERY DEPLETION IS SUSPECTED. DEVICE EXPLANTATION IS SCHEDULED ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S050616

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention