BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY 200

    MDR report key: 3775256 · Received April 25, 2014

    Report

    Report Number
    1000165971-2014-00123
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    December 26, 2013
    Report Date
    January 9, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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, NO VENTRICULAR SPIKE COULD BE PRODUCED WITH MAGNET APPLICATION AND IT WAS ALSO INDICATED THAT TELEMETRY SHOWED A LEAD IMPEDANCE GREATER THAN 3000 OHMS. THE SUBJECT PACEMAKER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252058 REPLY 200 NVZ SORIN GROUP ITALIA S.R.L. REPLY 200 SR 2726

    Patients

    Seq Age Sex Outcome Treatment
    1