BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3371208 · Received August 30, 2013

    Report

    Report Number
    1000165971-2013-00410
    Event Type
    Malfunction
    Date Received
    August 30, 2013
    Date of Event
    August 9, 2013
    Report Date
    August 14, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    G120093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 U.S.; HOWEVER, IT IS SIMILAR TO PARADYM RF CRT MODELS APPROVED UNDER P060027. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, WHEN THE PATIENT FILES FROM THE DAY OF IMPLANT ((B)(6) 2013) WERE ACCESSED, AN ERROR MESSAGE STATING "UNABLE TO READ FILE" WAS DISPLAYED TO THE USER. AN EXPLANATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430451 PARADYM NIK SORIN GROUP ITALIA S.R.L. PARADYM RF SONR 9770 2718

    Patients

    Seq Age Sex Outcome Treatment
    1