BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 3966637 · Received July 30, 2014

    Report

    Report Number
    1000165971-2014-00428
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 15, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE HAS BEEN PACING THE VENTRICLE AT 130MIN-1 FOR ONE WEEK WITHOUT ANY REASON. THE PATIENT CAME TO SEE THE CARDIOLOGIST BECAUSE SHE WAS BREATHLESS. THE DEVICE WAS INITIALLY PROGRAMMED TO DDIR 60MIN-1 (FBASE) / 130MIN-1 (FMAX). THIS INADEQUATE PACING IS REPORTEDLY NOT DUE TO THE SENSORS, ACCORDING TO THE AVAILABLE GRAPHS. NORMAL PACING RATE WAS RECOVERED AFTER A TEMPORARY PROGRAMMING TO DDI MODE AT 30MIN-1. AN EXPLANATION AND RECOMMENDATIONS WERE REQUESTED. PRELIMINARY ANALYSIS REVEALED THAT A SEU WAS MOST PROBABLY AT THE ORIGIN OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444932 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2410

    Patients

    Seq Age Sex Outcome Treatment
    1