BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 3190495 · Received June 21, 2013

    Report

    Report Number
    1000165971-2013-00302
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SORIN GROUP ITALIA 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

    ON (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

    DURING THE IMPLANTATION OF THE SUBJECT PACEMAKER, TEMPORARY PACING INHIBITION WAS OBSERVED AFTER A CARDIOVERSION SHOCK (150J - DELIVERED TO REDUCE AN ATRIAL FIBRILLATION). PACING MODE HAD BEEN RE-PROGRAMMED TO DOO/80MIN - 1 BEFORE THE SHOCK. DEFIBRILLATION PATCHES WERE PLACED ON THE CHEST AND BACK. AFTER THE SHOCK, PACING AT AROUND 30MIN- 1 WAS OBSERVED IN BOTH A AND V CHANNELS ON EXTERNAL ECG MONITOR; THE PACING RATE WAS BACK TO 80MIN - 1 AFTER A FEW SECONDS. THE MODE WAS THEN RE-PROGRAMMED TO DDD/60MIN -1 AND PROPER PACING WAS CONFIRMED. A NOISE OVERSENSING EPISODE (NON-PHYSIOLOGICAL SIGNALS) CORRELATED WITH THE DATE/TIME OF THE SHOCK WAS RECORDED IN THE IMPLANT MEMORIES. THE PHYSICIAN REQUESTED AN EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282545 REPLY NVZ SORIN GROUP ITALIA S.R.L REPLY DR 2667

    Patients

    Seq Age Sex Outcome Treatment
    1