BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2043267 · Received February 25, 2011

    Report

    Report Number
    1000165971-2011-00096
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 18, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2011 FOLLOW-UP, THE PHYSICIAN OBSERVED THAT THE ATRIUM, LEFT AND RIGHT VENTRICLE IMPEDANCE TREND CURVES WERE NOT AVAILABLE. HOWEVER, THE IMPEDANCE TEST PERFORMED DURING THE FOLLOW-UP DID NOT SHOW ANY ANOMALY. THE PHYSICIAN ASKED FOR AN EXPLANATION OF THE REPORTED BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM CRT 8750 2433

    Patients

    Seq Age Sex Outcome Treatment
    1