BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRON

    MDR report key: 191404 · Received October 9, 1998

    Report

    Report Number
    1640319-1998-00622
    Event Type
    Malfunction
    Date Received
    October 9, 1998
    Date of Event
    September 14, 1998
    Report Date
    September 14, 1998
    Manufacturer
    SULZER INTERMEDICS INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER INDICATED SUSPECTED OVERSENSING IN THE DEVICE. THE CHRONOLOG PRINTOUTS FAXED TO CO INDICATED ONE EPISODE OF APPROPRIATELY DETECTED AND TREATED VT (VENTRICULAR TACHYCARDIA) AND TWO EPISODES OF INAPPROPRIATE SHOCK DELIVERY INTO NORMAL SINUS RHYTHM/PACING (DOUBLE COUNTING OF THE R WAVE AND SINGLE SENSING OF THE T WAVE). CO'S ON-SITE ENGINEER WALKED THE PHYSICIAN THROUGH THE REPROGRAMMING OF THE SENSING MARGIN (2.7 TO 3.5:1) AND THIS RESOLVED THE OVERSENSING ACCORDING TO THE PHYSICIAN.

    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 70 YR 497-19 LEAD