BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1697643 · Received May 20, 2010

    Report

    Report Number
    1000165971-2010-00701
    Event Type
    Malfunction
    Date Received
    May 20, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 14, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 US; HOWEVER, IT IS SIMILAR TO REPLY DR MODEL 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), NORMAL MEASUREMENT WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM S.R.L. REPLY VDR 2355

    Patients

    Seq Age Sex Outcome Treatment
    1