MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT

Model Number LXMC13

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Pyrosis/Heartburn (1883); Nausea (1970)

Event Date 08/01/2018

Event Type  malfunction  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced pain, coughing, and ongoing gerd symptoms that led to x-ray visualization of the linx device open.This led to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hernia repair and linx device implantation occurred on (b)(6) 2015 by dr.(b)(6) at (b)(6) hospital.The patient reported that she had difficulties recovering from the implant procedure.Patient's reflux symptoms recurred in late summer or early fall 2017.She also began experiencing nausea and epigastric pain in fall 2017.Barium swallow exam on (b)(6) 2018 visualized the discontinuous device.Images showed that the device was intact; however, bead-to-bead separation was larger than normal.Device explant due to the device opening occurred without issue on (b)(6) 2018.A hernia repair and fundoplication were performed at the time of removal.It was noted that the linx was "well encapsulated, but upon dissection" the "capsule [was] noted to be open with [the] fractured wire on [the] lateral side of the esophagus".The device was cultured and showed "no suspicion of infection based on visual" inspection.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced pain, coughing, and ongoing gerd symptoms that led to x-ray visualization of the linx device open.This led to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hernia repair and linx device implantation occurred on (b)(6) 2015 by dr.(b)(6) at (b)(6).The patient reported that she had difficulties recovering from the implant procedure.Patient's reflux symptoms recurred in late summer or early fall (b)(6).She also began experiencing nausea and epigastric pain in fall (b)(6).Barium swallow exam on (b)(6) 2018 visualized the discontinuous device.Images showed that the device was intact; however, bead-to-bead separation was larger than normal.Device explant due to the device opening occurred without issue on (b)(6) 2018.A hernia repair and fundoplication were performed at the time of removal.It was noted that the linx was "well encapsulated, but upon dissection" the "capsule [was] noted to be open with [the] fractured wire on [the] lateral side of the esophagus".The device was cultured and showed "no suspicion of infection based on visual" inspection.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 7832792
• MDR Text Key: 118888193
• Report Number: 3008766073-2018-00141
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/13/2019
• Device Model Number: LXMC13
• Device Lot Number: 8164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 78 YR