BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1960330 · Received December 15, 2010

    Report

    Report Number
    1000165971-2010-01028
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., 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) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING A STANDARD F/U, THE PHYSICIAN WAS NOT ABLE TO ACCESS THE PROGRAMMING PARAMETERS OF THE RV LEAD, WHEREAS ATRIAL ONES WERE ACCESSIBLE. PHYSICIAN HAD TO REBOOT THE PROGRAMMER THEN INTERROGATE THE DEVICE IN ORDER TO BE ABLE TO PROGRAM THE PARAMETERS OF THE RV LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2483

    Patients

    Seq Age Sex Outcome Treatment
    1