BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 6048972 · Received October 21, 2016

    Report

    Report Number
    3008766073-2016-00075
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 27, 2016
    Report Date
    February 3, 2017
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005035
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    -UPDATE REGARDING REMOVAL OF REMAINDER OF BEADS FROM 3-4 MONTHS TO (B)(6) 2017. -DEVICE EVALUATION PERFORMED ON SINGLE EXPLANTED BEAD. 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. NO CONCLUSION RELEVANT TO EXPERIENCE DETERMINED.

    Additional Manufacturer Narrative · 1

    -UPDATE REGARDING REMOVAL OF REMAINDER OF BEADS FROM 3-4 MONTHS TO (B)(6) 2017. -DEVICE EVALUATION PERFORMED ON SINGLE EXPLANTED BEAD. 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. NO CONCLUSION RELEVANT TO EXPERIENCE DETERMINED. ESOPHAGEAL DILATION (B)(6) 2015, REMAINING DEVICE REMOVAL (B)(6) 2017, AND PATIENT STATUS AFTER REMOVAL. PARTIAL DEVICE RETURN.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE A PATIENT EXPERIENCED ABDOMINAL PAIN TO ENDOSCOPIC VISUALIZATION OF LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN ON (B)(6) 2016. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. -ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2012 BY DR. (B)(6). -A HIATAL HERNIA WAS REPAIRED AS PART OF THE ANTI-REFLUX PROCEDURE. -PATIENT REPORTED DIFFICULTIES SWALLOWING/DYSPHAGIA AFTER DEVICE IMPLANT. -ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2016 SHOWED LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN. -UNEVENTFUL ENDOSCOPIC EXPLANT OF SINGLE LINX BEAD ON (B)(6) 2016 BY DR. (B)(6) AT (B)(6). -PHYSICIAN PLANS TO LAPAROSCOPICALLY REMOVE THE REMAINDER OF THE LINX DEVICE IN (B)(6) 2017. PATIENT REPORTED AS DOING WELL.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED ABDOMINAL PAIN TO ENDOSCOPIC VISUALIZATION OF LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN ON (B)(6) 2016. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2012 BY DR. (B)(6). A HIATAL HERNIA WAS REPAIRED AS PART OF THE ANTI-REFLUX PROCEDURE. PATIENT REPORTED DIFFICULTIES SWALLOWING/DYSPHAGIA AFTER DEVICE IMPLANT. ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2016 SHOWED LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN. UNEVENTFUL ENDOSCOPIC EXPLANT OF SINGLE LINX BEAD ON (B)(6) 2016 BY DR. (B)(6) AT (B)(6). PHYSICIAN PLANS TO LAPAROSCOPICALLY REMOVE THE REMAINDER OF THE LINX DEVICE IN 3-4 MONTHS.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE A PATIENT EXPERIENCED ABDOMINAL PAIN LEADING TO ENDOSCOPIC VISUALIZATION OF LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN ON 09/27/2016 RESULTING IN DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. -ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2012 BY DR. (B)(6). -A HIATAL HERNIA WAS REPAIRED AS PART OF THE ANTI-REFLUX PROCEDURE. -PATIENT REPORTED DIFFICULTIES SWALLOWING/DYSPHAGIA AFTER DEVICE IMPLANT. -PATIENT HAD AN ESOPHAGEAL DILATION ON (B)(6) 2015 WITH NO RESOLUTION. -ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2016 SHOWED LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN. -UNEVENTFUL ENDOSCOPIC EXPLANT OF SINGLE LINX BEAD ON (B)(6) 2016 BY DR. (B)(6) AT (B)(6). -UNEVENTFUL LAPAROSCOPIC EXPLANT OF THE REMAINING 11 LINX DEVICE BEADS ON (B)(6) 2017. -PATIENT WAS REPORTED AS DOING WELL AND HAD NO COMPLAINTS AFTER REMOVAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699691 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LX12 2451 00855106005035

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| S