BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2492764 · Received March 9, 2012

    Report

    Report Number
    1000165971-2012-00101
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    January 27, 2012
    Report Date
    February 23, 2012
    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) 2012. 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 CRT MODELS APPROVED UNDER P060027. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE ICD INVOLVED IN THIS MDR REPORT WAS EXPLANTED BECAUSE OF AN INFECTION DUE TO (B)(6) AND GLOBAL SEPTICAEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM SONR 8770 2493

    Patients

    Seq Age Sex Outcome Treatment
    1