MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC14; ANTI-REFLUX IMPLANT

Model Number LXC-[14]

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

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Vomiting (2144); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 08/26/2020 date of event: only event year is known: 2019.Additional information was requested, and the following was received: were there any other contributing factors that led to the removal of the device other than the reported dysphagia? yes, ¿regurgitation, emesis, and fear of eating¿ the patient will not eat in public, has decreased appetite, and this results in significant isolation.His primary complaints are the feeling of heartburn, food getting stuck, and vomiting.¿ what was the reason for removal of the linx device? ¿despite multiple interventions and diet and lifestyle modifications, he still persists with complaints of prolonged dysphagia.¿ was the device found in the correct position/geometry at the time of removal? ¿no abnormalities were noted.The linx device could be seen around the distal esophagus.It appeared to be in good position.¿ prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? patient completed an egd/bx/48 hour ph and video esophagram.No manometry.What is the product code for the linx device that was removed? model number: lxc14, serial number: (b)(4).What is the lot number of the linx device? lot number: 5286.When using the linx sizing device what technique was used to determine the size? per operative note: the sizing device was brought up into the operative field and measurements were then taken of the esophageal circumference.Based on this, 14-b device was then chosen.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? inhaled budesonide for aspiration pneumonitis.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? cerebral palsy, epilepsy, congenital scoliosis.Difficult to assess if patient was having dysphagia as he was not verbal and all symptoms were provided by his mother.Primary pre-op symptom was vomiting/cough.How severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? a.No.

Event Description

It was reported that a linx device was explanted on (b)(6) 2019 due to dysphagia.No other information is available.

Manufacturer Narrative

(b)(4).Date sent: 9/21/2020.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 5286 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 9/28/2020.Please see attached medical records.

• Brand Name: LXC14
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10454934
• MDR Text Key: 204688858
• Report Number: 3008766073-2020-00131
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005158
• UDI-Public: 00855106005158
• 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,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: 09/23/2017
• Device Model Number: LXC-[14]
• Device Catalogue Number: LXC14
• Device Lot Number: 5286
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/08/2020; 09/24/2020
• Supplement Dates FDA Received: 09/21/2020; 09/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention