BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM CRT

    MDR report key: 1556531 · Received December 7, 2009

    Report

    Report Number
    1000165971-2009-00077
    Event Type
    Malfunction
    Date Received
    December 7, 2009
    Date of Event
    November 2, 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 OVATIO CRT MODEL APPROVED UNDER P060027. (B) (4) - RECORDED EPISODES COULD NOT BE FOUND IN DEVICE MEMORY, AS EXPECTED. THE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING THE DEVICE ROUTINE FOLLOW-UP, THERE WAS A CRASH OF THE PROGRAMMER SOFTWARE DURING MEMORIES READING. LATER, NO RECORDED EPISODES COULD BE RETRIEVED FROM DEVICE MEMORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM CRT NIK - DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRON NIK SORIN BIOMEDICA CRM S.R.L. 8770 2295

    Patients

    Seq Age Sex Outcome Treatment
    1