BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM 2

    MDR report key: 2833467 · Received October 26, 2012

    Report

    Report Number
    1000165971-2012-00403
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 9, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SUBJECT DEMO DEVICE WAS INTERROGATED IN ITS BOX BY THE SUBSIDIARY ON (B)(4) 2012. REPORTEDLY, A KNOWN PROGRAMMER SOFTWARE ISSUE (ATP SETTINGS ARE CHANGED WHEN "FIRST INTERROGATION" IN THE PRE-PROGRAMMED MODES IS CLICKED) HAS BEEN CORRECTED FOR PARADYM ICD MODELS, BUT IS STILL OBSERVED WITH THIS PARADYM 2 ICD UPON INTERROGATION WITH 2.36J SOFTWARE VERSION. THE CUSTOMER REQUESTS A CORRECTION FOR PARADYM 2 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM 2 NIK SORIN C.R.M., S.R.L. PARADYM 2 CRT 8752 2643

    Patients

    Seq Age Sex Outcome Treatment
    1