MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number LXMC15

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2020 as the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot number was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? how many dilations did the patient have? on what date(s) did the dilation (s) take place? on what date did the implant take place? what is the product code for the linx device that was removed? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the dilation of the device other than the reported dysphagia? when and if the linx device is removed, may we ask that the device be returned for analysis? may we please reach back out to you in mid-january 2021 to confirm the device was explanted?.

Event Description

It was reported that post-implant of an unknown linx device, the patient experienced ongoing dysphagia despite dilation.The device remains implanted.

Manufacturer Narrative

(b)(4).Date sent: 3/9/2021.Additional information was requested, and the following was obtained: did the explant take place on (b)(6) 2021? prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? how many dilations did the patient have? on what date(s) did the dilation (s) take place? on what date did the implant take place? what is the product code for the linx device that was removed? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the dilation of the device other than the reported dysphagia? is the device being returned for analysis? answer = no additional information from the surgeon has been received at this time.

Manufacturer Narrative

(b)(4).Date sent: 2/19/2021.Additional information was requested, and the following was obtained: we were able to confirm with the surgeon that the removal is scheduled on (b)(6).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: did the explant take place on (b)(6) 2021? prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? how many dilations did the patient have? on what date(s) did the dilation (s) take place? on what date did the implant take place? what is the product code for the linx device that was removed? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids/immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the dilation of the device other than the reported dysphagia? is the device being returned for analysis?.

Manufacturer Narrative

(b)(4).Date sent: 4/13/2021.Additional information was requested, and the following was obtained: original implant date: (b)(6) 2020.Explant date: (b)(6) 2021.Cause of explant was persistent dysphagia on improvement with gerd symptoms.Lxmc15.Lot unknown.Measures taken to resolve issues: continue soft diet, medrol dose pack, restarted dexilant 17 days post op.Recommended measures refused by patient.Endoscopic dilation, repeat manometry, ph testing.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11096296
• MDR Text Key: 225725781
• Report Number: 3008766073-2020-00203
• Device Sequence Number: 1
• Product Code: LEI
• 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,Followup,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention