BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1960331 · Received December 15, 2010

    Report

    Report Number
    1000165971-2010-01029
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 10, 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
    GM
    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

    SINCE PATIENT COMPLAINED ABOUT HIGH RATE PACING AND NO ANOMALY WAS OBSERVED BY THE PHYSICIAN IN THE PATIENT MEMORY DATA, AN ECG EXAM WAS PERFORMED. DEVICE WAS PROGRAMMED IN RATE RESPONSIVE MODE. ALTHOUGH, PATIENT WAS AT REST, ATRIAL PACING EPISODES WERE OBSERVED, FOLLOWED BY VENTRICULAR PACING OR SENSING AT A RATE BETWEEN 110 AND 140 BPM. IN ADDITION, PHYSICIAN OBSERVED LONGER AV DELAY THAN PROGRAMMED. DEACTIVATING OF VENTILATION MINUTE SENSOR MIGHT HAVE SOLVED THE OBSERVED BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2360

    Patients

    Seq Age Sex Outcome Treatment
    1