MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Model Number LXMC13

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pain (1994); No Code Available (3191)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 08/26/2020.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? yes.¿she had bravo ph testing done at usc by dr.Steve demeester in 2011 that was reportedly positive¿ ¿video esophagram performed in march showed normal esophageal motility¿ what is the lot number of the lxmc13 linx device? lot number: 10253 / serial number: (b)(4).When using the linx sizing device what technique was used to determine the size? ¿a small window was then created between the posterior vagus and esophagus.Through this window, the sizing device was then placed.Based on these measurements, a 13-bead device was then chosen.¿ 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)? yes.¿she complains of typical symptoms of heartburn, esophageal dysphagia and supine regurgitation for which she needs to sleep with the head of her bed elevated.¿ how severe was the dysphagia/odynophagia before intervention? ¿occasional esophageal 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? yes.A 3cm hiatal hernia repair.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia and pain? ¿mrs.Hughes does report resolution of heartburn and reflux symptoms, consistent with results of recent surveillance workup, however she complains of daily dysphagia and "pain above and below the level of the linx." she states she has restarted ppi and famotidine medications without improvement.She has undergone dilatations to the linx and reports very temporary improvement from regurgitation symptoms only.She states the only thing that helps with the discomfort is hyoscyamine, however she is concerned about taking anticholinergic medications in general, let alone long term if her symptoms do not improve.She is requesting the linx to be removed as she has become intolerant of the device.She otherwise denies f/c, cough, sob, n/v or cp.¿ was the device found in the correct position/geometry at the time of removal? yes have the symptoms resolved since the device was explanted? yes.¿mrs.Hughes states her dysphagia symptoms have resolved.She states she no longer feels the "strangle hold" around her esophagus when eating.¿.

Event Description

It was reported that a linx device was explanted on (b)(6) 2019 due to dysphagia and pain above and below the device.

Manufacturer Narrative

(b)(4).Date sent: 9/29/2020.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 10253 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10455084
• MDR Text Key: 204523227
• Report Number: 3008766073-2020-00133
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

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 Expiration Date: 02/17/2020
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 10253
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 09/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention