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

Catalog Number LXM15

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/24/2020.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.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, cardia insufficiency, slidingl hiatus hernia.When using the linx sizing device what technique was used to determine the size? to measure the gastro-esophageal junction without bougie , till it opens und reading the number and we choose a band number 3 points above the measured number.Did the patient have an autoimmune disease? no history of autoimmune disease.Is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.How severe was the dysphagia/odynophagia before intervention? no dysphagia.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? dorsal hiatoplasty.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? 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)? the band was in normal position, no signs of dislocation and good transit of contrast using barium swallow and also egd.Clarification needed based on what was reported and what was received in follow up: the event description states: ¿the patient again suffer from dysphagia¿.The additional information states: ¿no dysphagia¿.Did the patient have dysphagia? what was the reason for the explant? the event description state: ¿the implanted linx was not in his original condition, it was trapped in the hiatus.¿ the additional information states: ¿the band was in normal position, no signs of dislocation and good transit of contrast using barium swallow and also egd¿.At the time of the explant, was the device found in the correct anatomical position? response: the sales representative was present during the explantation, but not when the linx was implanted.The information in the event description is correct.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.Described the position of the linx device at the time of removal.Did the patient have a reoccurring hiatal hernia at the time of the 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)?.

Event Description

It was reported, lxm15, lot unknown.Implanted on (b)(6) 2019 in (b)(6).Re-presentation at the hospital in (b)(6) 2020.The patient again suffer from dysphagia, increased high ph value.The implanted linx was not in his original condition, it was trapped in the hiatus.On (b)(6) 2020 the linx band was explanted in castrup-rauxel.

Manufacturer Narrative

(b)(4).Date sent: 10/12/2020.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.Additional information was requested, and the following was obtained: described the position of the linx device at the time of removal? linx was between the hiatus hernia.Did the patient have a reoccurring hiatal hernia at the time of the removal? no did it appear that the position of the device had changed since the implant procedure? no.

• Brand Name: LINX 1.5T 15 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10442214
• MDR Text Key: 204342203
• Report Number: 3008766073-2020-00124
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: LXM15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR