BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 2992970 · Received March 1, 2013

    Report

    Report Number
    9610579-2013-00016
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 12, 2013
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS INTERROGATED TWICE ON (B)(6) 2012, AT 10H42 AND 12H24, PROGRAMMER TIME. AN UN-EXPLAINED BRADYCARDIA EPISODE (CORRESPONDING TO A SWITCH IN DDD MODE WHILE THE DEVICE IS PROGRAMMED IN SAFER PACING MODE) WAS OBSERVED IN DEVICE MEMORY. IT SHOULD BE NOTED THAT EPISODE WAS RECORDED AT THE TIME OF FIRST DEVICE INTERROGATION (ON (B)(6) 2012).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89916 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S040325

    Patients

    Seq Age Sex Outcome Treatment
    1