BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3695797 · Received January 17, 2014

    Report

    Report Number
    1000165971-2014-00015
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Date of Event
    December 4, 2013
    Report Date
    December 20, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    G120093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2014. 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, ARTIFACT WAS OBSERVED ON THE ATRIAL LEAD OF THE ICD. THE LEAD AND THE ICD WERE EXPLANTED. THE ICD WILL BE RETURNED FOR ANALYSIS. THIS CASE IS ASSOCIATED TO SORIN LEAD COMPLAINT REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44853 PARADYM NIK SORIN GROUP ITALIA S.R.L. PARADYM RF SONR 9770 2492

    Patients

    Seq Age Sex Outcome Treatment
    1