BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1755436 · Received June 16, 2010

    Report

    Report Number
    1000165971-2010-00750
    Event Type
    Malfunction
    Date Received
    June 16, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 1, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CRT MODELS APPROVED UNDER P060027. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING THE ROUTINE FOLLOW-UP OF THE DEVICE INVOLVED IN THIS REPORT, THE PHYSICIAN REPORTED THAT HE OBSERVED THE PROGRAMMING OF THE DEVICE WAS DIFFERENT FROM THE PROGRAMMING AT PREVIOUS FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM NIK SORIN BIOMEDICA CRM S.R.L. PARADYM SONR 8770 2410

    Patients

    Seq Age Sex Outcome Treatment
    1