MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC13; ANTI-REFLUX IMPLANT

Catalog Number LXC13

Device Problems Fluid/Blood Leak (1250); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pocket Erosion (2013); Hernia (2240); No Code Available (3191)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: (b)(6) 2020.(b)(4).The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.The device remains implanted.Additional information received: do you have the linx product code, lot number and serial number (if applicable)? no sure, he does have his card saying he can't go into an mri.On what date was the device implanted in (b)(6) of 2016? unknown.Were there any intra-operative complications during implant? not to the patient¿s knowledge.It worked fine for a year.He started to have reflux and didn't want to lay down.He found a linx surgeon in (b)(6) who wanted to take the device out and do a fundoplication.He was a snowbird at the time.Dr.(b)(6) said he was one of the first to have it done and it would of also fixed his hiatal hernia.Was there any hiatal or crural repair done at the same time as the implant? hiatal hernia was done at a second surgery.He was the 72nd to ever have the linx device implanted.He had the hernia fixed and about two three years since he's had issues.He's had part of his lung removed.The reflux went down his trachea according to dr.T.He's starting to cough and has an irritated trachea.His most painful surgery was the lung removal.Have you had a follow-up appointment with the surgeon that implanted the linx device or another physician? (b)(6) he has an appoint with a linx surgeon in fl.6) have you had any diagnostic testing done to address the symptoms that you have been experiencing? yes, "all that".One of the most painful ones he had done when the tube was shoved down his throat.That was done prior to the implant.He also did an acid test.Additional information received: after the initial surgery of the implant of the lynx, which worked for about a year, my gerd returned.My surgeon then performed a hiatal hernia repair, which worked for about 4 years until the gerd returned.My surgeon in (b)(6), (b)(6)., performed an endoscopy and found the lynx has moved above the diaphragm.He also said he could see the lynx from inside the esophagus.He feels the lynx may be too tight and is eroding my esophagus.Very scary! he recommended replacing the current lynx with one that is not as tight or a nissen fundoplication.I am scheduled for a cat scan (b)(6) to be sure he knows what is going on before we proceed with a surgery.On (b)(6) 2020: spoke with the patient.On (b)(6) 2020 he had an endoscopy done.The doctor thinks that the linx is too tight and not allowing all the food to get through.The doctor also stated that there were no esophageal problems which the patient stated ¿which was good.¿ he also stated that dr.(b)(6) thinks the linx has moved and has eroded into his esophagus.He had a test done which showed that he was only digesting half of the food and dr.(b)(6) started him on generic nexium as this caused in increase in the acid.The patient stated that he had a ct scan prior to the one on the (b)(6) but he guessed it did not show anything and he does not know the results of the ct scan that was done on (b)(6) 2020.The patient will follow-up with dr.(b)(6) and obtain medical records/images, results of ct scan and find out what the management plan will be.He will update us with any additional information obtained.

Event Description

It was reported that the linx device implanted in april 2016 may be leaking because when he lies prone he gets mild gerd.Patient age: (b)(6) (male).

Manufacturer Narrative

(b)(4).Date sent: 04/22/2020.H6: patient code: gastroparesis.Additional information received: information provided by the patient.Patient had follow-up appointment with his doctor.Information was provided to the sales rep per the doctor.The explant surgery for (b)(6), 2020 has been cancelled as the hospital has cancelled all elective surgeries due to the virus.This will be re-scheduled at least 4-weeks out, but no surgery date has been provided.Per the patient, the surgeon feels that the device is too tight as the patient is having a lot of burping.The plan is to take the old linx device out and replace with a larger one if possible.If not, a fundoplication will be done.The device has moved above the diaphragm related to a recurrent hernia that was fixed during the initial implant surgery.1.Why is the linx being removed? device is being removed because patient has become symptomatic with gerd and i believe dysphagia.Has had the device for 7+ years and the imaging suggest that there is a hiatal hernia recurrence which has resulted in the linx device herniating up into the thoracic cavity and thus not effectively opening and closing.A.Did the device erode? no erosion as far as i am aware information provided by the sales rep.

Manufacturer Narrative

(b)(4).Date sent: 05/14/2020.Additional information received: the lxc13 was removed and replaced with an lxmc17.A mesh was also placed.Explant was done on (b)(6) 2020.

• Brand Name: LXC13
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9800642
• MDR Text Key: 185661640
• Report Number: 3008766073-2020-00043
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2020

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: LXC13
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/30/2020; 05/12/2020
• Supplement Dates FDA Received: 04/22/2020; 05/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR