BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1880932 · Received October 1, 2010

    Report

    Report Number
    1000165971-2010-00921
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 15, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING ROUTINE FOLLOW-UP, THE DEVICE WAS FOUND OPERATING WITH NOMINAL PARAMETERS AFTER A RESET. THE PHYSICIAN REQUESTED AN EXPLANATION ABOUT THE RESET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA CRM S.R.L. PARADYM CRT 8750 2366

    Patients

    Seq Age Sex Outcome Treatment
    1