BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 4231959 · Received November 6, 2014

    Report

    Report Number
    1000165971-2014-00615
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE SUBJECT PACEMAKER COULD NOT BE INTERROGATED BUT STILL RESPONDED TO MAGNET AT 96MIN-1. INTERROGATION ATTEMPTS WERE REPEATED IN MULTIPLE POSITION BY DIFFERENT OPERATORS BUT FAILED. THE DEVICE WILL BE EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, THE SUBJECT PACEMAKER COULD NOT BE INTERROGATED BUT STILL RESPONDED TO MAGNET AT 96MIN-1. INTERROGATION ATTEMPTS WERE REPEATED IN MULTIPLE POSITION BY DIFFERENT OPERATORS BUT FAILED. THE DEVICE WILL BE EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714502 SYMPHONY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN CRM SYMPHONY DR 2550 S070216

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R