BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2992934 · Received March 1, 2013

    Report

    Report Number
    1000165971-2013-00108
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    SORIN CRM S.R.I.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE: 03/01/2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    UPON A PACEMAKER CHECK ON (B)(6) 2013, DISCREPANCY BETWEEN THE PROGRAMMER SCREEN AND THE PRINTED DATA WAS OBSERVED: WHEN A PART OF THE 24 HOUR HEART RATE CURVE WAS PRINTED, THE PRINTOUT SHOWED ANOTHER PERIOD (WITH A WRONG DATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89294 REPLY NVZ SORIN CRM S.R.I. REPLY DR 2576

    Patients

    Seq Age Sex Outcome Treatment
    1