MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Hernia (2240); No Code Available (3191)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Pc (b)(4).Additional information was requested, and the following was received: on what date did the implant take place? (b)(6) 2020 does the patient have any of the allergies to metals? no if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunization drugs? no did the patient have any pre-existing dysphagia or other conditions (other than gerd)? i do not know, i will ask the surgeon.Was there any hiatal or crural repair done at the same time as the implant? yes was mesh used at time of implant? no what was the reason for removal of the linx device? the stomach had herniated through the linx device and there was a massive recurrent paraesophageal hernia at the time of removal, was the device found in the correct position/geometry at the time of removal? no have the symptoms resolved since the device was explanted? i do not know because the linx was not found in the original position, described the position of the linx device at the time of removal.It appeared as though the linx was partially adhered to the diaphragm (anterior) and had stomach herniated through the device.Did the patient have a hiatal hernia at the time of the removal? yes, a paraesophageal hernia was present at the time of removal.Did it appear that the position of the device had changed since the implant procedure? how was this change observed (intra-operatively at the time of explant, x-rays, barium swallow, egd)? in the additional information it is stated: ¿the stomach had herniated through the linx device and there was a massive recurrent paraesophageal hernia¿.Does this mean the device had eroded into the stomach? no, there was no erosion.Instead it appeared to look like it migrated to the stomach.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? you quoted.Please reply when you have the answer.I have not heard back from the surgeon yet.Have the symptoms resolved since the device was explanted? i have not heard back from the surgeon yet.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that the linx is being removed.The case is being completed.

Manufacturer Narrative

(b)(4).Date sent: 11/16/2020.Device analysis: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The dhr for lot: 24787 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10763025
• MDR Text Key: 213900900
• Report Number: 3008766073-2020-00166
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

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: Health Professional
• Device Expiration Date: 03/26/2023
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 24787
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/16/2020
• Patient Sequence Number: 1
• Patient Age: 70 YR