BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1994393 · Received January 14, 2011

    Report

    Report Number
    1000165971-2011-00017
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 24, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NIK
    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. 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

    THE ICD INVOLVED IN THIS REPORT WAS IMPLANTED ON (B)(6) 2010. UPON SCHEDULED F/U ON (B)(6) 2010, THE IMPLANT MEMORIES COULD NOT BE READ (HOLTER MEMORIES WERE EMPTY: NO HEART RATE CURVE, ¿). STATISTICS F/U PERIOD WAS DISPLAYED AS "FROM (B)(6)". AN EXPLANATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM NIK SORIN BIOMEDICA CRM S.R.L. PARADYM SONR 8770 2461

    Patients

    Seq Age Sex Outcome Treatment
    1