BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 1556532 · Received December 7, 2009

    Report

    Report Number
    1000165971-2009-00080
    Event Type
    Malfunction
    Date Received
    December 7, 2009
    Date of Event
    November 11, 2009
    Report Date
    November 13, 2009
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    P060027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MODEL APPROVED UNDER P060027. THE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION PROCEDURE, LEAD IMPEDANCE MEASUREMENT AFTER FIRST INDUCTION SHOCK WERE ABNORMALLY HIGH. DESPITE NO CHANGE IN THE LEADS CONNECTION INTO THE DEVICE PORT, LATER MEASUREMENTS RESULTED IN NORMAL IMPEDANCE VALUES, EVEN AFTER A SECOND INDUCTION SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM NIK - DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRON NIK SORIN BIOMEDICA CRM S.R.L. PARADYM DR 2378

    Patients

    Seq Age Sex Outcome Treatment
    1