MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Apnea (1720); Asthma (1726); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pain (1994); Hernia (2240)

Event Date 05/23/2018

Event Type  Injury  

Event Description

It was reported that the patient had a linx device implanted in (b)(6) 2014.The patient is having difficulties with the linx from the first day of implant.Something bothered the patient in the neck / larynx / trachea / esophagus.There have been a few gastroscopies.Possible side effects of the operation.The patient did not want to take out the linx.Then the patient started having issues with air shortage at different intervals once with chest - once with bad pain in 2016, the distances became shorter and shorter.There was another surgery.There was room and the patient was ready for the air.There were other things with surgery, after the gastroscopy always calm down first with the complaints.Last year, the patient was stretched.The linx was in the stomach and then there were great pain in this area that went away again and then came back.Currently the patient has this shortage of air again in shorter intervals.A sting like nail stings in the neck and once the patient had over half a day first belly / then chest and then those throat complaints and also had the sting in the neck.This linx is always to blame.The patient wants to know if there is a drug that could help.

Manufacturer Narrative

(b)(4).Exact implant date is unknown.Device was implanted in (b)(6) 2015.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.Additional information provided: second opinions have been sought after by patient.Patient sufferers from swallowing difficulties.Also suffers from shortness of breath.Pulmonologist opinion said it is from reflux.This issue has a negative effect on patients asthma.Surgeon operated on patient and found that a part of the linx tape has slipped into the diaphragmatic hernia.The patient wanted to have the linx removed but the doctor would not remove the device.The patient now can only eat soft food for 3 weeks and not exercise for 6 weeks.The patient has had endless gastroscopies in different hospitals.The patient is also on medications and has side effects.The patient then had a reconstruction because the linx was not in the correct position anymore and the hernia was ignored.The patient suffered from more shortness of breath.Now in august the linx has been stretched and so far i haven't had any chest cramps but the pain in the larynx area is back.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: what is the product code? what is the lot number? what does it mean when the event description states ¿the linx was no longer on¿? was the linx discontinues? did the linx migrate? if yes for migration, where was the linx? has the linx been removed? if yes when was the linx explant date? what is the status of the patient? will the device be returning for analysis? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 6/1/2022 g3 and report submission due date.

Manufacturer Narrative

(b)(4).Date sent: 6/14/2022.Additional information received: is there the possibility that the linx device migrated due to that the hernia was not repaired first during the implantation in 2014? difficult to know, but an enlarging hiatal hernia would cause the ge junction to be situated above the diaphragm.Whether the device is still at the ge junction is unclear to me.If it is, then the device hasn¿t migrated, the ge junction has.Sounds like maybe recurrent gerd, given the ¿throat pain¿.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• 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: 14517932
• MDR Text Key: 292983903
• Report Number: 3008766073-2022-00106
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2022

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 07/02/2016; 06/02/2022
• Supplement Dates FDA Received: 06/01/2022; 06/14/2022
• 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
• Patient Outcome(s): Required Intervention