BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 3820909 · Received May 20, 2014

    Report

    Report Number
    1000165971-2014-00284
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS SHOWED THAT THE SWITCH IN STANDBY MODE WAS CAUSED BY A TEMPORARY ABRUPT DECREASE OF DEVICE INTERNAL POWER SUPPLY. NORMAL BEHAVIOR WAS RESTORED AFTER PACEMAKER REINITIALIZATION.

    Description of Event or Problem · 1

    PACEMAKER WAS FOUND IN STANDBY MODE AND RE-INITIALIZED. UNIPOLAR SENSING REPORTEDLY CAUSED MYOPOTENTIALS OVERSENSING AND PATIENT'S DIZZINESS.

    Description of Event or Problem · 1

    PACEMAKER WAS FOUND IN STANDBY MODE AND REINITIALIZED. UNIPOLAR SENSING REPORTEDLY CAUSED MYOPOTENTIALS OVERSENSING AND PATIENT'S DIZZINESS.

    Description of Event or Problem · 1

    PACEMAKER WAS FOUND IN STANDBY MODE AND RE-INITIALIZED. UNIPOLAR SENSING REPORTEDLY CAUSED MYOPOTENTIALS OVERSENSING AND PATIENT'S DIZZINESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299811 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM RHAPSODY + DR 2530 S060629

    Patients

    Seq Age Sex Outcome Treatment
    1