BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2915536 · Received January 10, 2013

    Report

    Report Number
    1000165971-2013-00013
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 18, 2012
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING LAST PLANNED F/U ON (B)(4) 2012, THE SORIN TECHNICIAN OBSERVED AN UNEXPLAINED EGM SIGNAL (NOISY PATTERN) IN A TREATED FAST VT EPISODE. AN EXPLANATION ABOUT THIS BEHAVIOUR IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15054 PARADYM NIK SORIN C.R.M., S.R.L. PARADYM CRT 8750 2540

    Patients

    Seq Age Sex Outcome Treatment
    1