BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3658023 · Received November 15, 2013

    Report

    Report Number
    1000165971-2013-00532
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Date of Event
    September 23, 2013
    Report Date
    October 24, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    G120093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 P060027. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    AN ATRIAL AMPLITUDE MEASUREMENT ISSUE WAS REPORTEDLY OBSERVED DURING SENSING TESTS, LEADING TO THE STORAGE OF AN ERRONEOUS MINIMUM ATRIAL AMPLITUDE VALUE IN DEVICE MEMORIES. AN ANALYSIS IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594537 PARADYM NIK SORIN GROUP ITALIA S.R.L. PARADYM RF SONR 9770 2603

    Patients

    Seq Age Sex Outcome Treatment
    1