BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 5043406 · Received August 31, 2015

    Report

    Report Number
    3008766073-2015-00032
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    July 30, 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 09/03/2015 BY MANUFACTURER: ENDOSCOPIC REMOVAL OF 2 BEADS VISIBLE IN ESOPHAGEAL LUMEN WAS CONDUCTED ON (B)(6) 2015 AFTER COMPLETION OF PATIENT'S VACATION. LOOP CUTTER USED TO CUT WIRES CONNECTING BEADS OF INTACT LINX DEVICE TO ALLOW FOR REMOVAL. REMAINING DEVICE PLANNED TO BE REMOVED LAPAROSCOPICALLY AT A LATER DATE. PATIENT CONDITION REPORTED AS WELL FOLLOWING THE EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    -ENDOSCOPIC REMOVAL OF 2 BEADS VISIBLE IN ESOPHAGEAL LUMEN WAS CONDUCTED ON (B)(6) 2015 AFTER COMPLETION OF PATIENT'S VACATION. -LOOP CUTTER USED TO CUT WIRES CONNECTING BEADS OF INTACT LINX DEVICE TO ALLOW FOR REMOVAL. -REMAINING DEVICE PLANNED TO BE REMOVED LAPAROSCOPICALLY AT A LATER DATE. -PATIENT CONDITION REPORTED AS WELL FOLLOWING THE EXPLANT PROCEDURE. DATA RECEIVED 12/10/2015 BY MANUFACTURER: -LAPAROSCOPIC REMOVAL OF REMAINDER OF DEVICE COMPLETED (B)(6) 2015. -PATIENT CONDITION REPORTED AS WELL FOLLOWING THE EXPLANT PROCEDURE. -DEVICE ANALYSIS CONDUCTED BY TORAX MEDICAL ENGINEERING AFTER PRODUCT RECEIPT OF ENDOSCOPIC REMOVAL. 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. -LOT NUMBER #3280, SERIAL NUMBER #(B)(4) CORRECTED (NUMBERS HAD BEEN TRANSPOSED). (B)(4).

    Additional Manufacturer Narrative · 1

    DATA RECEIVED 09/03/2015 BY MANUFACTURER: -ENDOSCOPIC REMOVAL OF 2 BEADS VISIBLE IN ESOPHAGEAL LUMEN WAS CONDUCTED ON (B)(6) 2015 AFTER COMPLETION OF PATIENT'S VACATION. -LOOP CUTTER USED TO CUT WIRES CONNECTING BEADS OF INTACT LINX DEVICE TO ALLOW FOR REMOVAL. -REMAINING DEVICE PLANNED TO BE REMOVED LAPAROSOPICALLY AT A LATER DATE. -PATIENT CONDITION REPORTED AS WELL FOLLOWING THE EXPLANT PROCEDURE. DATA RECEIVED 12/10/2015 BY MANUFACTURER: -LAPAROSCOPIC REMOVAL OF REMAINDER OF DEVICE COMPLETED (B)(6) 2015. -PATIENT CONDITION REPORTED AS WELL FOLLOWING THE EXPLANT PROCEDURE. -DEVICE ANALYSIS CONDUCTED BY TORAX MEDICAL ENGINEERING AFTER PRODUCT RECEIPT OF ENDOSCOPIC REMOVAL. 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. -LOT NUMBER #3280, SERIAL NUMBER #(B)(4) CORRECTED (NUMBERS HAD BEEN TRANSPOSED).

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA 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) 2014. ENDOSCOPY COMPLETED(B)(6) 2015 DUE TO DYSPHAGIA REVEALED TWO BEADS (TITANIUM ENCASED MAGNETS) TO BE VISIBLE IN THE ESOPHAGUS. THE LINX DEVICE WAS INTACT. DYSPHAGIA REPORTED TO HAVE ORIGINATED IN (B)(6) 2015. LAPAROSCOPIC REMOVAL OF THE ENTIRE LINX DEVICE IS PLANNED FOR (B)(6) 2015 BASED ON PATIENT'S SCHEDULE.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA 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) 2014. ENDOSCOPY COMPLETED (B)(6) 2015 DUE TO DYSPHAGIA REVEALED TWO BEADS (TITANIUM ENCASED MAGNETS) TO BE VISIBLE IN THE ESOPHAGUS. THE LINX DEVICE WAS INTACT. DYSPHAGIA REPORTED TO HAVE ORIGINATED IN (B)(6) 2015. LAPAROSCOPIC REMOVAL OF THE ENTIRE LINX DEVICE IS PLANNED FOR (B)(6) 2015 BASED ON PATIENT'S SCHEDULE.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA 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) 2014. -ENDOSCOPY COMPLETED (B)(6) 2015 DUE TO DYSPHAGIA REVEALED TWO BEADS (TITANIUM ENCASED MAGNETS) TO BE VISIBLE IN THE ESOPHAGUS. THE LINX DEVICE WAS INTACT. DYSPHAGIA REPORTED TO HAVE ORIGINATED IN (B)(6) 2015. -LAPAROSCOPIC REMOVAL OF THE ENTIRE LINX DEVICE IS PLANNED FOR (B)(6) 2015 BASED ON PATIENT'S SCHEDULE.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA 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) 2014. -ENDOSCOPY COMPLETED (B)(6) 2015 DUE TO DYSPHAGIA REVEALED TWO BEADS (TITANIUM ENCASED MAGNETS) TO BE VISIBLE IN THE ESOPHAGUS. THE LINX DEVICE WAS INTACT. DYSPHAGIA REPORTED TO HAVE ORIGINATED IN (B)(6) 2015. -LAPAROSCOPIC REMOVAL OF THE ENTIRE LINX DEVICE IS PLANNED FOR (B)(6) 2015 BASED ON PATIENT'S SCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575224 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LX12 3280

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| S