BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRON

    MDR report key: 131532 · Received November 5, 1997

    Report

    Report Number
    1640319-1997-01117
    Event Type
    Malfunction
    Date Received
    November 5, 1997
    Date of Event
    October 3, 1997
    Report Date
    October 6, 1997
    Manufacturer
    SULZER INTERMEDICS INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED AND THE EVENT COULD NOT BE DUPLICAYED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED BEING UNABLE TO VISUALIZE STORED IEGMS POST INDUCTION. THE SIGNAL LOOKED LIKE A "PRESSURE MONITOR" WITH GRADUAL ELEVATION FROM THE BASELINE WITH A SUDDEN DROP OFF. THRESHOLDS WERE GOOD AND THE REALTIME IEG'S WERE OK. ALL THE OTHER CHRONOLOG DATA WAS PRESENT AND APPEARS APPROPRIATE. AN ATTEMPT TO RE-ACQUIRE WAVEFORM STORAGE AFTER THE PROGRAMMING VENTRICLE FILTERED IN CHRONOLOG SETUP WAS UNSUCCESSFUL. SIGNALS WERE FOUND TO BE PRESENT AT THE END OF THE BUFFER. ON 10/10, THE REPORTER SPOKE WITH THE NURSE AT THE HOSP. SHE SAW THE PT WITH THE CHRONOLOG ANOMALY AND THE BATTERY VOLTAGE IS FINE. THERE WERE NO EVENTS TO ASSESS WHETHER THE CHRONOLOG PROBLEM HAS BEEN RESOLVED. THE PT WILL BE SEEN IN THE NEXT COUPLE OF WEEKS FOR A FOLLOW-UP EP INDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRON Implant IMPLANTABLE DEFIBRILLATOR LWS SULZER INTERMEDICS INC. 101-09 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 497-19-2289 (LEAD).| RX5000 (PROGRAMMER)