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

Model Number LXMC17

Device Problems Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Swelling/ Edema (4577)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Additional information was requested, and the following was obtained: please explain what the patient experienced immediate intolerance to liquids or solids means? he could not tolerate liquids or solids reliably starting on pod #0.Was it difficult for the patient to swallow? yes.Did the explant take place (b)(6) 2021? 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? yes.Ph study was abnormal at demeester 37.8; manometry was normal (dc! >5000, 10/10 effective swallows).What is the lot number of the linx device? unknown.When using the linx sizing device what technique was used to determine the size? visual inspection, pop-off + 3.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no previous dysphagia.Has had moderately controlled dm2 for many years.How severe was the dysphagia/odynophagia before intervention? very.9 days post op was not tolerating any solids and liquids poorly.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? difficulty swallowing in conjunction with poor po intake and my concern on its effect on his dm regimen.Besides the reported dysphagia, what was the reason for removal of the linx device? as above.Was the device found in the correct position/geometry at the time of removal? yes.There was minimal capsule formation and the device was unbuckled and removed.What is the surgeon experience with the device? 7-10 implants previously.Prior to linx placement, did the patient have an egd, ph, barium study and manometry studies done? if yes, could you please share the results? as above.Also had ugi which showed only radiographic reflux, and did not demonstrate the hh that was found and repaired at surgery.Will the device be returned for analysis? no.

Event Description

It was reported that post implant of lxmc17, the patient experienced immediate intolerance to liquids or solids.Upper gi performed and the liquid was slow to transit through linx.Upon removal of the device, severe edema.

• 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
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN 55126 ; 6107428552
• MDR Report Key: 11627287
• MDR Text Key: 244286559
• Report Number: 3008766073-2021-00069
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

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 Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention