BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE-FIXATION LEAD

    MDR report key: 753005 · Received August 16, 2006

    Report

    Report Number
    2938836-2006-00632
    Event Type
    Injury
    Date Received
    August 16, 2006
    Date of Event
    February 27, 2006
    Report Date
    July 31, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE HOSP RETURNED THE DEVICE USED IN THIS EVENT. THEY ALSO RETRURNED THE MALLINCKRODT INTUBATION STYLET FOR PERFORMANCE TESTING PURPOSES. THE CUSTOMER FELT THAT THEY LIKELY CAUSE OF THE EVENT WAS THE STYLET, HOWEVER, THEY REQUESTED AN EVAL ON OUR ENDOTRACHEAL TUBE TO ASSURE THAT IT WAS WITHIN SPECIFICATION. THE MANUFACTRUING RECORDS WERE REVIEWED AND THERE WAS NO INDICATION OF PROBLEMS DURING MFR. A REVIEW OF OUR COMPLAINTS DATABASE REVEALS NO SIMILAR REPORTS OF THIS DEVICE. THE RETURNED ENDOTRACHEAL TUBE WAS VIEWED TO ASSURE NO DAMAGE, DISTORTION OR OBSTRUCTIONS. NONE WERE FOUND. THE TUBE WAS INSPECTED FOR DIMENSIONS BEING ACCORDING TO SPECIFICATION AND THEY WERE. THE ID OF THE TUBE WAS MEASURED TO ASSURE THAT IT WAS WITHIN SPECIFICATION WITH NO BURRS OR SHARP EDGES ON THE ID OF THE CONNECTOR. IT PASSED TESTING. A FUNCTIONAL TEST WAS PERFORMED TO ASSURE THAT A SMITHS MEDICAL 6FR SUCTION CATHETER WOULD PASS THROUGH THE TUBE WITH NO DIFFICULTIES. THE MALLINCKRODT INTUBATION STYLET WAS VIEWED AND AN ATTEMPT WAS MADE TO STRAIGHTEN THE REC'D STYLET AS BEST AS POSSIBLE. THE STRAIGHTENED STYLET WAS INSERTED INTO THE ET TUBE AND WITHDRAWN WITHOUT DIFFICULTY. VISUAL EXAMINATION SHOWED THAT PART OF THE STYLET COVER WAS MISSING: APPROXIMATELY 55MM LENGTH FROM THE STYLET TIP. CONCLUSION: DUE TO THE ENDOTRACHEAL TUBE PASSING DIMENSIONAL, VISUAL AND FUNCTIONAL TESTING, SMITHS MEDICAL CONCLUDES THAT THE CAUSE OF THIS EVENT WAS THE MALLINCKRODT INTUBATION STYLET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPOSITIONED DUE TO DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE-FIXATION LEAD DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC. 1581/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention THERAPY DATES