BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2997646 · Received March 6, 2013

    Report

    Report Number
    1000165971-2013-00125
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    G120093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING. 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.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A FOLLOW-UP ON (B)(6) 2013, AN ANOMALY WAS OBSERVED IN THE DISPLAYED HEART RATE CURVE. AN EXPLANATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96117 PARADYM NIK SORIN CRM S.R.L. PARADYM RF SONR 9770 0

    Patients

    Seq Age Sex Outcome Treatment
    1