BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 2093304 · Received April 15, 2011

    Report

    Report Number
    1000165971-2011-00163
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Report Date
    March 29, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (B)(4). ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE ICD INVOLVED IN THIS MDR REPORT HAS BEEN EXPLANTED FOLLOWING PT DEATH DUE TO SEVERE HEART FAILURE. DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM NONE NIK SORIN CRM S.R.L. PARADYM SONR 8770 2385

    Patients

    Seq Age Sex Outcome Treatment
    1