BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPREME EP CATHETER, BIPOLAR, 6F

    MDR report key: 2932465 · Received January 24, 2013

    Report

    Report Number
    3005188751-2013-00011
    Event Type
    Injury
    Date Received
    January 24, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DRF
    PMA / PMN Number
    K002976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE SUPREME ELECTROPHYSIOLOGY CATHETER IFU INDICATES THE DEVICE CAN BE USED IN THE EVALUATION OF A VARIETY OF CARDIAC ARRHYTHMIAS FROM ENDOCARDIAL AND INTRAVASCULAR SITES. THE SUPREME ELECTROPHYSIOLOGY CATHETER IFU CAUTIONS THE DEVICE SHOULD ONLY BE USED BY PHYSICIANS THOROUGHLY TRAINED IN THE TECHNIQUE OF ANGIOGRAPHY AND ELECTROPHYSIOLOGY AND INTRACARDIAC RECORDING AND STIMULATION. THE SUPREME ELECTROPHYSIOLOGY CATHETER IFU STATES RISKS ASSOCIATED WITH THE USE OF THE DEVICE ARE RISKS RELATED TO CARDIAC CATHETERIZATION IN GENERAL, SUCH AS THROMBOEMBOLISM, CARDIAC PERFORATION, TAMPONADE, AND INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS ADMITTED TO THE HOSPITAL FOR COMPLETE HEART BLOCK AND A SUPREME ELECTROPHYSIOLOGY CATHETER WAS INSERTED AS A TEMPORARY PACEMAKER AND CONNECTED TO A PORTABLE STIMULATOR. IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. ECHOCARDIOGRAPHY REVEALED A CARDIAC TAMPONADE THAT DID NOT REQUIRE SURGICAL INTERVENTION. A PERMANENT PACEMAKER WAS IMPLANTED AND THE CURRENT CONDITION OF THE PATIENT IS STABLE. THE PHYSICIAN STATED THERE WAS NO PERFORMANCE ISSUE WITH THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34569 SUPREME EP CATHETER, BIPOLAR, 6F DIAGNOSTIC EP CATHETERS DRF ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 401956 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention