BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1880830 · Received October 1, 2010

    Report

    Report Number
    1000165971-2010-00914
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 9, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE US. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE US; HOWEVER, IT IS SIMILAR TO PARADYM CRT MODELS APPROVED UNDER P060027. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING THE DEVICE INTERROGATION, IT WAS REPORTED THAT NO INFO WAS AVAILABLE FROM DEVICE MEMORY (AIDA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM NIK SORIN BIOMEDICA C.R.M., S.R.L. PARADYM SONR 8770 2448

    Patients

    Seq Age Sex Outcome Treatment
    1