BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIFIX EZ

    MDR report key: 79065 · Received March 21, 1997

    Report

    Report Number
    1640319-1997-00262
    Event Type
    Malfunction
    Date Received
    March 21, 1997
    Date of Event
    January 24, 1997
    Report Date
    March 21, 1997
    Manufacturer
    SULZER INTERMEDICS, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SEEN ON 1/14/97 AND A FLUOROSCOPIC EXAM OF HIS LEAD SHOWED THAT IT HAD DISLODGED. PACING PRODUCED POCKET STIMULATION SO OVO WAS PROGRAMMED. A WEEK LATER THE PT RECEIVED INAPPROPRIATE SHOCKS AND WAS ADMITTED TO THE HOSP. THE LEAD HAD PULLED OUT EVEN FURTHER. THE DECISION WAS MADE TO REMOVE THE SYSTEM (EXCEPT FOR THE EPICARDIAL PATCHES) AND IMPLANT A DIFFERENT SYSTEM. UPON REMOVAL OF THE SYSTEM, IT WAS NOTED THAT ALL OF THE CAP SCREWS WERE ON THE DEVICE AND ALL OF THE LEADS AND ADAPTERS WERE IN EXCELLENT CONDITION. THE ENDOCARDIAL LEAD WAS EXTRACTED AND THE EPICARDIAL PATCHES WERE CAPPED AND LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIFIX EZ Implant PACEMAKER LEAD DTB SULZER INTERMEDICS, INC. 438-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR 522-06-04438 (PROGRAMMER). 531-52-101149 (SOFTWARE