BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2151526 · Received June 24, 2011

    Report

    Report Number
    1000165971-2011-00229
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 7, 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)(6), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2011 FOLLOW-UP, THE PHYSICIAN OBSERVED THAT A WARNING RELATED TO SUSPECT ABNORMAL LEFT VENTRICULAR LEAD IMPEDANCE MEASURED ON (B)(6) 2010 WAS DISPLAYED TO THE USER. HOWEVER, ALL THE OTHER FOLLOW-UP DATA WERE NORMAL. THE PHYSICIAN ASKED FOR AN ANALYSIS OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM CRT 8750 2435

    Patients

    Seq Age Sex Outcome Treatment
    1