BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1960313 · Received December 15, 2010

    Report

    Report Number
    1000165971-2010-01019
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 29, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DECEMBER (B)(4) 2010. 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 OF THE DEVICE INVOLVED IN THIS REPORT, A WARNING MESSAGE RELATED TO LOW IMPEDANCE OBSERVED ONE DAY OVER THE FOLLOW-UP PERIOD WAS DISPLAYED. HOWEVER, ALL FOLLOW-UP DATA INDICATED NORMAL IMPEDANCE VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA CRM S.R.L. PARADYM DR 8550 2399

    Patients

    Seq Age Sex Outcome Treatment
    1