BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2093308 · Received April 15, 2011

    Report

    Report Number
    1000165971-2011-00161
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 25, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, VENTRICULAR BURST EPISODES WERE RECORDED IN DEVICE MEMORY; AN EXPLANATION WAS REQUESTED IN ORDER TO CLARIFY THE WAY TO CALCULATE THE PACING INTERVALS WITH HYSTERESIS AND RATE SMOOTHING SETTING THESE RECORDED VENTRICULAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY SR 2435

    Patients

    Seq Age Sex Outcome Treatment
    1