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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Dysphagia/ Odynophagia (1815); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Nausea (1970); Anxiety (2328); Depression (2361)

Event Date 10/01/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: do you have the linx product code (model number), lot number and serial number (if applicable)? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? have you had a follow-up appointment with the surgeon that implanted the linx device? have you had any diagnostic testing done to address the symptoms you have been experiencing? if yes, what diagnostic testing was done and have you received the test results? do we have permission to contact the physician that did the implant? if yes, what is the surgeon's name, address and telephone number.This is the only information i have on the linx.It was placed (b)(6) 2017 at (b)(6) hospital in (b)(6) by dr.(b)(6).I was told that he also did a revision repair to the paraesophageal hernia with mesh.We had not discussed or had i confirmed he could use mesh.I had very little information on the linx or mesh.I followed up earlier that i was supposed to because of pain and swallowing issues.I had 4 different contacts with dr (b)(6) after the surgery.I was told it would take time to heal and to adjust to the linx.I was then referred back to my gastrointestinal specialist dr (b)(6).I have had colonoscopies and endoscopy since that surgery.At my last egd at (b)(6) center.Approx (b)(6) 2018 i was told by dr.(b)(6) that if i wanted, he would refer me back to dr.(b)(6) for linx removal.We have discussed all the pain, swallowing issues, stomach problems with poor absorption, ibs, multiple medication tries and changes and fails, gerd and the fact that i may have developed gastroparesis as well.Life has not been easy and there are multiple times that i've wanted to give up because of all the problems.I did have to give up my job as well which has put me on disability and change my life for the worst.If there's anything anymore you need to know about the lakes or surgery please contact me i am willing to discuss with you.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.May we have permission to contact dr.(b)(6) to obtain further details?.

Event Description

Patient had original hiatal hernia mesh implanted in 2009 after eleven years of internal bleeding.I had been getting it for infusions and blood transfusions.After years of weekly hospital stays, medical treatments, and medications, i traveled to (b6) in (b6).I had a paraesophageal hernia with eight bleeding ulcers and a nissan fundoplication with mesh was performed.Within seven months i was in worse pain.I had ibs, hypertension, gerd, depression, anxiety, difficulty swallowing, headaches, eye issues, fatigue, constipation, diarrhea, flu like symptoms, bloating gas, indigestion, sour stomach, bad breath.All doctors felt that the bleeding had stopped with the mesh, so i no longer had any issues with the procedure done to treat the bleed.The pain grew worse year after year, week after week, and day by day.I wanted to die to get rid of all the new symptoms and diagnosis i had developed.I had egds and colonoscopies done yearly.My gastroenterologist finally decided i needed to consult with a surgeon.I was referred to and consulted with two - three before anyone would discuss doing a revision.I had a revision done in 2017.The surgeon told my family he did not find any mesh, but i was full of adhesions.Adhesion removal took four hours of surgery.My liver and stomach had to be removed from the inside of my esophagus and stomach had to be tacked in place.I had developed a new hiatal hernia and new ulcers as well as the old hernia was inside my esophagus.While waiting for a doctor to try and find the mesh issues, i also lost (b6).I was malnourished, lacked in vitamins.The surgeon in 2017 was only to place a linx, but without permission, placed a new mesh and a linx.I am also needing to report i have still been having same problems and cannot swallow.I have developed gastroparesis since that surgery.No one can tell if it is from the mesh or the linx.I need both the previous mesh and the new mesh as well as the linx reviewed by the fda as the original mesh nor the linx were approved.Device is not available for return.

• 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: 8253663
• MDR Text Key: 133260534
• Report Number: 3008766073-2019-00256
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/16/2019
• 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