BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 3202207 · Received June 28, 2013

    Report

    Report Number
    1000165971-2013-00310
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 13, 2013
    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

    (B)(4) 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 ROUTINE CHECK OF THE SUBJECT PACEMAKER ON (B)(6) 2013, THE FIRST INTERROGATION ATTEMPT FAILED. SECOND ATTEMPT WITH ANOTHER PROGRAMMER WAS SUCCESSFUL. PROPER INTERROGATION OF ANOTHER PACEMAKER WAS CONDUCTED WITH BOTH PROGRAMMERS ON (B)(6) 2013. IT WAS NOT POSSIBLE TO REPRODUCE THE PHENOMENON. THE PHYSICIAN REQUESTED AN EXPLANATION ABOUT THE INTERROGATION FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295313 REPLY NVZ SORIN GROUP ITALIA S.R.L. REPLY DR 2482

    Patients

    Seq Age Sex Outcome Treatment
    1