BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 4868617 · Received June 23, 2015

    Report

    Report Number
    3008766073-2015-00024
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 22, 2015
    Report Date
    June 12, 2017
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA RECEIVED 08/20/2015 BY MANUFACTURER: -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

    DATA RECEIVED 08/20/2015 BY MANUFACTURER: -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.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED PAIN LEADING TO VISUALIZATION OF LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION REPORTED AS (B)(6) 2012. ENDOSCOPY COMPLETED (B)(6) 2015 DUE TO PAIN REVEALED TWO BEADS (TITANIUM ENCASED MAGNETS) TO BE VISIBLE IN TH ESOPHAGUS. THE LINX DEVICE WAS INTACT. LAPAROSCOPIC REMOVAL FO THE ENTIRE LINX DEVICE OCCURRED (B)(6) 2014. 360 DEGREE FUNDOPLICATION PERFORMED AT THE TIME OF LINX DEVICE EXPLANT. ENDOSCOPY COMPLETED (B)(6) 2015 DEMONSTRATED NORMAL RESULTS (NO LEAKAGE, STENOSIS, ETC.). PATIENT IS REPORTED AS WELL

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED PAIN LEADING TO VISUALIZATION OF LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. -ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION REPORTED AS (B)(6) 2012. -ENDOSCOPY COMPLETED (B)(6) 2015 DUE TO PAIN REVEALED TWO BEADS (TITANIUM ENCASED MAGNETS) TO BE VISIBLE IN THE ESOPHAGUS. THE LINX DEVICE WAS INTACT. -LAPAROSCOPIC REMOVAL OF THE ENTIRE LINX DEVICE OCCURRED (B)(6) 2015. -360 DEGREE FUNDOPLICATION PERFORMED AT TIME OF LINX DEVICE EXPLANT. -ENDOSCOPY COMPLETED (B)(6) 2015 DEMONSTRATED NORMAL RESULTS (NO LEAKAGE, STENOSIS, ETC.) -PATIENT IS REPORTED AS WELL.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED PAIN LEADING TO VISUALIZATION OF LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. -ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION REPORTED AS (B)(6) 2012. -ENDOSCOPY COMPLETED (B)(6) 2015 DUE TO PAIN REVEALED TWO BEADS (TITANIUM ENCASED MAGNETS) TO BE VISIBLE IN THE ESOPHAGUS. THE LINX DEVICE WAS INTACT. -LAPAROSCOPIC REMOVAL OF THE ENTIRE LINX DEVICE OCCURRED (B)(6) 2015. -A 360 DEGREE FUNDOPLICATION PERFORMED AT TIME OF LINX DEVICE EXPLANT. -ENDOSCOPY COMPLETED (B)(6) 2015 DEMONSTRATED NORMAL RESULTS (NO LEAKAGE, STENOSIS, ETC.) -PATIENT IS REPORTED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406801 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LX13 3235

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| S