BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 5252374 · Received November 26, 2015

    Report

    Report Number
    1000165971-2015-00730
    Event Type
    Injury
    Date Received
    November 26, 2015
    Date of Event
    October 27, 2015
    Report Date
    November 2, 2015
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED REPORT.

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS SHOWED THAT THE DEVICE OPERATED AS SPECIFIED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE SUBJECT DEVICE REPLACEMENT, THE PACEMAKER STARTED TO PACE IN VVI MODE AT 96 MIN-1 WITHOUT THE PRESENCE OF A MAGNET. IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE ELECTROCAUTERY. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE SUBJECT DEVICE REPLACEMENT, THE PACEMAKER STARTED TO PACE IN VVI MODE AT 96 MIN-1 WITHOUT THE PRESENCE OF A MAGNET. IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE ELECTROCAUTHERY. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE SUBJECT DEVICE REPLACEMENT, THE PACEMAKER STARTED TO PACE IN VVI MODE AT 96 MIN-1 WITHOUT THE PRESENCE OF A MAGNET. IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE ELECTROCAUTHERY. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782326 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY SR 2250 S061002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention