BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2980696 · Received February 22, 2013

    Report

    Report Number
    1000165971-2013-00079
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    G120093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    REPORTEDLY, DURING A FOLLOW-UP PERFORMED ON (B)(6) 2013 FOR A PACEMAKER-DEPENDANT PT, ONE EPISODE OF VENTRICULAR OVERSENSING RESULTING IN A VENTRICULAR PAUSE WAS RECORDED ON (B)(6) 2013. IDENTIFICATION OF THE SOURCE OF THE NOISE AND RECOMMENDATION WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77974 PARADYM NIK SORIN CRM S.R.L. PARADYM RF SONR 9770 2650

    Patients

    Seq Age Sex Outcome Treatment
    1