BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1800098 · Received August 10, 2010

    Report

    Report Number
    1000165971-2010-00864
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 30, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 REPLY DR OR SR MODELS APPROVED UNDER P950029. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE VENTRICULAR LEAD IMPEDANCE CURVE RECORDED IN DEVICE MEMORY SHOWED HIGH IMPEDANCE (> 3 KOHM). HOWEVER, DURING THE LATEST FOLLOW-UP ON (B)(6) 2010, NORMAL MEASUREMENT WAS OBTAINED. THE ATRIAL LEAD IMPEDANCE CURVE ALSO SHOWED SOME HIGH IMPEDANCES VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM S.R.L. REPLY VDR 2373

    Patients

    Seq Age Sex Outcome Treatment
    1