BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITM

    MDR report key: 183380 · Received August 19, 1998

    Report

    Report Number
    183380
    Event Type
    Death
    Date Received
    August 19, 1998
    Date of Event
    June 12, 1998
    Report Date
    July 13, 1998
    Manufacturer
    SULZER INTERMEDICS INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS TAKEN TO THE CATH LAB TO PERFORM CARDIOVERSION. IMPLANTABLE DEFIBRILLATOR FAILED TO READ APPROPRIATE RHYTHM AND CREATED A DYSRHYTHMIA. SECOND DEFIBRILLATOR USED BUT WAS UNSUCCESSFUL IN CONVERTING PT AND PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITM Implant IMPLANTABLE DEFIBRILLATOR DTB SULZER INTERMEDICS INC. 497-23 NA
    2 ITM Implant IMPLANTABLE DEFIBRILLATOR LWS SULZER INTERMEDICS, INC. 101-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death DEVICE LEADS