BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2980694 · Received February 22, 2013

    Report

    Report Number
    1000165971-2013-00078
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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, A RV THRESHOLD TEST WAS PERFORMED DURING THE FOLLOW-UP OF (B)(6) 2013 AND THE PROGRAMMER SCREEN FROZE AT THE END OF THIS TEST. AN EXPLANATION IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77978 PARADYM NIK SORIN CRM S.R.L. PARADYM CRT 8750 2526

    Patients

    Seq Age Sex Outcome Treatment
    1