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

Catalog Number LXMC17

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pneumonia (2011); Vomiting (2144); No Code Available (3191)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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? on what date did the implant take place? 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? it was reported that the patient experienced dysphagia and continuation of pre-implant extraesophageal symptoms.What were the extraesophageal symptoms? did they contribute to the reason for removal? was the device found in the correct position/geometry at the time of removal?.

Event Description

It was reported that post-implant of the device the patient experienced dysphagia and the continuation of pre-implant extraesophageal symptoms.The device was explanted and discarded.The pre-op explant bravo test was not abnormal for gerd.There were no complications during the procedure.

Manufacturer Narrative

(b)(4).Date sent: 10/09/2019.The dhr for lot 24041 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was received: prior to linx placement, did the patient have an egd, ph, and manometry studies done? yes if yes, could you please share the results? unavailable but ph test did not illustrate an abnormal demeester score on what date did the implant take place? (b)(6) 2019 when using the linx sizing device what technique was used to determine the size? tendency toward upsizing ¿ majority of patients get a size 17 implant did the patient have an autoimmune disease? unknown is the patient currently taking steroids / immunization drugs? unknown did the patient have any pre-existing dysphagia or other conditions (other than gerd)? esophageal spasm with vomiting, chronic cough, aspiration pneumonia, hiatal hernia how severe was the dysphagia/odynophagia before intervention? unknown were there any intra-operative complications during implant? not that i¿m aware of was there any hiatal or crural repair done at the same time as the implant? yes it was reported that the patient experienced dysphagia and continuation of pre-implant extraesophageal symptoms.What were the extraesophageal symptoms? esophageal spasm with vomiting, chronic cough, aspiration pneumonia did they contribute to the reason for removal? yes was the device found in the correct position/geometry at the time of removal? yes.

• 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: 9139212
• MDR Text Key: 163121797
• Report Number: 3008766073-2019-00485
• 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: 09/17/2019

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: 11/12/2022
• Device Catalogue Number: LXMC17
• Device Lot Number: 24041
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/18/2019
• Patient Sequence Number: 1
• Patient Age: 58 YR