BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3775254 · Received April 25, 2014

    Report

    Report Number
    1000165971-2014-00114
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    December 17, 2013
    Report Date
    December 20, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 RF VR MODELS APPROVED UNDER P980049. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    A DEVICE RESET OCCURRED ON (B)(6) 2013 (DAY OF IMPLANTATION) FOR THE SUBJECT DEVICE. IN ADDITION, ISSUES WERE REPORTEDLY NOTICED IN THE PATIENT FILES SAVED ON (B)(6) 2013: R WAVE AMPLITUDE MEASUREMENTS PERFORMED BEFORE DEVICE IMPLANTATION WERE SAVED IN DEVICE MEMORIES; THE BATTERY VOLTAGE AND/OR THE BATTERY CURVE WAS NOT DISPLAYED; EPISODES THAT HAPPENED BEFORE DEVICE IMPLANTATION WERE LISTED IN THE ARRHYTHMIA HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250861 PARADYM MRM SORIN GROUP ITALIA S.R.L. PARADYM VR 8252 2737

    Patients

    Seq Age Sex Outcome Treatment
    1