BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 5032295 · Received August 26, 2015

    Report

    Report Number
    1000165971-2015-00523
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 30, 2015
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REPORTEDLY, BATTERY IMPEDANCE VALUE HAS REMAINED UNCHANGED DURING THE CONSECUTIVE FOLLOW-UPS.

    Description of Event or Problem · 1

    REPORTEDLY, BATTERY IMPEDANCE VALUE HAS REMAINED UNCHANGED DURING THE CONSECUTIVE FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566244 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM RHAPSODY SR 2210

    Patients

    Seq Age Sex Outcome Treatment
    1