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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Obstruction of Flow (2423)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information: yes, i have contacted the surgeon who implanted the device with regards to my symptoms.He has advised me that it is necessary to have the device removed asap.The surgeon is (b)(6) in (b)(6).Since speaking with dr.(b)(6), i have met with other physicians/surgeons who are familiar with the lynx both implanting and explanting.At this time, i am not having the device explanted.2 lynx surgeons suggested that before explanting i should have a dilation.I have just had this done.Additional information was requested, and the following was obtained: how did the dilation work? what are the next steps for this patient? (b)(6) at dr.(b)(6)¿s office returned my call and stated that they have not seen (b)(6) since (b)(6).Dr.(b)(6) told the patient that they would remove the linx.(b)(6) stated that the patient was getting a second opinion from another doctor or doctors.She did not know who those doctors were or who was doing the dilations.Spoke with the patient and i shared that i had reached out to dr.(b)(6)¿s office related to obtaining additional information about her recent dilation and it was shared that they had not seen her since (b)(6) and that she was getting a second opinion from another doctor or possibly doctors.I shared that (b)(6) at dr.(b)(6)¿s office requested that she contact them and provide an update.(b)(6) shared that she no longer sees dr.(b)(6).Dr.(b)(6) recommended that the device be removed.She has followed up with several gastroenterologists and with doctors who are familiar and experienced with the linx.Dr.(b)(6) disagreed with removing the linx and wanted to try dilation.She had a dilation with fluro done approximately two weeks ago that was done by dr.(b)(6).¿dr.(b)(6) was able to loosen 3 beads.There was no food in the esophagus and no erosion, everything looked good.¿ she is having no symptoms right now, but she stated that she knows of things that aggravate it and she knows the link.She will follow back up with dr.(b)(6) in (b)(6).This follow-up is to make sure everything is still going well.The patient will contact us in the future if anything changes.

Event Description

It was reported that the linx device implanted about 2 ½ years ago by a doctor in (b)(6).Since that time, she has had recurrent issues with dysphagia and a hyperactive salivary gland.She has had numerous egd¿s and food particles have been found in her esophagus, other times she has had complete obstruction due to large bolus of food.She has given permission to contact implanting surgeon.

• 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: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 8304758
• MDR Text Key: 134994684
• Report Number: 3008766073-2019-00267
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2019

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: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/05/2019
• 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