BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2855908 · Received November 30, 2012

    Report

    Report Number
    1000165971-2012-00468
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 20, 2012
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    G1200093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012 - THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO PARADYM RF CRT MODELS APPROVED UNDER P060027. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2012, A HIGH SHOCK COIL IMPEDANCE WAS OBSERVED. AN EXPLANATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM NIK SORIN C.R.M., S.R.L. PARADYM RF SON R9770 2638

    Patients

    Seq Age Sex Outcome Treatment
    1