BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 5697399 · Received June 3, 2016

    Report

    Report Number
    3008766073-2016-00043
    Event Type
    Injury
    Date Received
    June 3, 2016
    Date of Event
    May 5, 2016
    Report Date
    March 6, 2017
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005028
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS CONDUCTED BY TORAX MEDICAL ENGINEERING AFTER PRODUCT RECEIPT. GROSS ANALYSIS REVEALED NO DEVICE ANOMALIES ATYPICAL FROM AN EXPLANTED DEVICE. MICROSCOPIC ANALYSIS REVEALED ALL DEVICE COMPONENTS AND ASSEMBLY EXHIBITED NORMAL CHARACTERISTICS OF AN EXPLANTED DEVICE. FORCE TESTING, LENGTH TESTING, AND GEOMETRIC ANALYSIS EXHIBITED NO ANOMALIES. NO CONCLUSION RELEVANT TO EXPERIENCE DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS CONDUCTED BY TORAX MEDICAL ENGINEERING AFTER PRODUCT RECEIPT. GROSS ANALYSIS REVEALED NO DEVICE ANOMALIES ATYPICAL FROM AN EXPLANTED DEVICE. MICROSCOPIC ANALYSIS REVEALED ALL DEVICE COMPONENTS AND ASSEMBLY EXHIBITED NORMAL CHARACTERISTICS OF AN EXPLANTED DEVICE. FORCE TESTING, LENGTH TESTING, AND GEOMETRIC ANALYSIS EXHIBITED NO ANOMALIES. NO CONCLUSION RELEVANT TO EXPERIENCE DETERMINED. FOLLOW UP #2 UPDATE/CORRECTION TO INCLUDE A PRESCRIPTION OF VALIUM AND DILATION PERFORMED PRIOR TO DEVICE REMOVAL. UPDATE TO INCLUDE AN EGD AND BARIUM SWALLOW EXAM PERFORMED PRIOR TO DEVICE REMOVAL.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2014. AFTER IMPLANT THE PATIENT REFUSED DILATIONS TO TREAT DYSPHAGIA. UNEVENTFUL DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA ON (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. DYSPHAGIA REPORTED AS RESOLVED AFTER DEVICE EXPLANT.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2014. AFTER IMPLANT THE PATIENT REFUSED DILATIONS TO TREAT DYSPHAGIA. UNEVENTFUL DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA ON (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. DYSPHAGIA REPORTED AS RESOLVED AFTER DEVICE EXPLANT.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2014. PATIENT EXPERIENCED SOME DYSPHAGIA AS OF AN APPOINTMENT ON (B)(6) 2016 AND WAS PRESCRIBED VALIUM. A PNEUMATIC DILATION WAS PERFORMED ON (B)(6) 2016 WITH SOME RELIEF; DYSPHAGIA WAS BACK BY (B)(6) 2016. AFTER IMPLANT THE PATIENT REFUSED FURTHER DILATIONS TO TREAT DYSPHAGIA. UNEVENTFUL DEVICE EXPLANT DUE TO MODERATE DYSPHAGIA ON (B)(6) 2016. LINX DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY. DYSPHAGIA REPORTED AS RESOLVED AFTER DEVICE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351368 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LS13 5478 00855106005028

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| S