BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2982071 · Received February 8, 2013

    Report

    Report Number
    1000165971-2013-00056
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 30, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    G120093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013. 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 (B)(4). ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    UPON ICD INTERROGATION ON (B)(4) 2013, A WARNING MESSAGE WAS DISPLAYED STATING THAT THE DEFIBRILLATION SYSTEM MAY BE INEFFECTIVE. AN ANALYSIS IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55375 PARADYM NIK SORIN CRM S.R.L. PARADYM RF SONR 9770 2605

    Patients

    Seq Age Sex Outcome Treatment
    1