BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3597674 · Received November 22, 2013

    Report

    Report Number
    1000165971-2013-00545
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Date of Event
    August 14, 2013
    Report Date
    October 30, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L
    Product Code
    NVZ
    PMA / PMN Number
    G120093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE (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 P060027. ANALYSIS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE ATRIAL SENSING TEST SOMETIMES DISPLAYED RESULTS LOWER THAN THE AMPLITUDES EFFECTIVELY OBSERVED DURING THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610941 PARADYM NVZ SORIN GROUP ITALIA S.R.L PARADYM RF SONR 9770 2607

    Patients

    Seq Age Sex Outcome Treatment
    1