MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Model Number LXMC16

Device Problems Device Appears to Trigger Rejection (1524); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Inflammation (1932); Vomiting (2144); Weight Changes (2607); Speech Disorder (4415)

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: pt had 80% incarcerated hiatal hernia - couldn't swallow or get any air in - no gerds, but surgeon stated that esophageal sphincter was "too stretched out" so patient needed a linx or nissen fundoplication.Patient has not been able to eat or drink and continues to lose weight quickly.Surgeon states that everything is normal and just give it time.Xray was done and linx in proper place.Mri done yesterday on a.7t mri and there was too much artifact to get a clear picture and patient reported chest pressure and burning after being removed from mri.Referred patient to surgeon.No lot number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: linx 16 beads lrg lxmc16 (b)(6) 2022.Was given 2 courses of prednisone and librax for swelling by surgeon (dr.Huget) for problems with linx.Not currently taking.Still having problems.Was told to give it time for symptoms to correct and given a follow up for 8 weeks.Was told to go to imaging center and that they will no longer see patient because of the linx.Their machine is.7 tesla and patient had a reaction.

Event Description

It was reported a linx device implanted on (b)(6) 2022 and the patient is currently having issue.Patient had a really tough recovery and still having food back up on him and has currently lost thirty pounds due to the issue.Patient stated he¿s also had voice problems, hoarseness, laryngitis and change in voice.Patient had an mri yesterday and was unable to complete and when patient was pulled out, he had a tight feeling in his chest and was having a hard time swallowing but it went away after a while.Tech stated that his implant was giving interference and unable to give a clear image.Patient worried that the mri may have cause some damage.

Manufacturer Narrative

(b)(4).Date sent: 5/24/2022.Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.Additional information received: patient called stating he had a reaction to the mri and is very concerned about it.He stated that he is still regurgitating food.He does have a surgeon he is talking to.Patient was referred to find another surgeon if his surgeon wouldn¿t see him.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: orla o'mahony ; 4188 lexington avenue north; shoreview 55126
• MDR Report Key: 14281867
• MDR Text Key: 290694533
• Report Number: 3008766073-2022-00092
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/08/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1