BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 3202196 · Received June 28, 2013

    Report

    Report Number
    9610579-2013-00048
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    REPORTEDLY, UNEXPECTED REPROGRAMMING OF THE RATE RESPONSE (SENSOR) PARAMETER WAS OBSERVED: PARAMETER WAS SET AT "MEDIUM" ON (B)(6) 2013 AND IT WAS FOUND AT "LOW" ON (B)(4) 2013. THE PT COMPLAINED ABOUT HIGH HEART RATE AT LOW LEVEL OF EXERCISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295927 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S071213

    Patients

    Seq Age Sex Outcome Treatment
    1