MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Model Number LXMC14

Device Problem Nonstandard Device (1420)

Patient Problems Dysphagia/ Odynophagia (1815); Muscle Spasm(s) (1966); Nausea (1970); Vomiting (2144); Burning Sensation (2146); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2019.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The dhr for lot 11366 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Lot 11366 was an affected lot of the 2018 linx recall.Per photographic evaluation by ethicon medical safety officer: reviewed an upright ap film of a patient with an implanted linx device.The linx device appeared circular in configuration and intact.Unable to determine exact position but it appeared above the stomach fundus and presumably around the lower esophagus.Additional information: no intra operative complications during implant.There was a hiatal or crural repair done at the time of implant.Gerd significant, nausea, no vomiting.Occasionally diarrhea.She takes levsin once a week.Senses of urgency to have bm, lots of gas.20-year history of gerd.Typical heartburn: yes burning in chest - worse with coffee, tomatoes, acidic foods, spicy foods.Regurgitation: yes, occasional, worse with lying down and bending over, once/month.Has to eat much earlier, won't eat before goes to bed at least 4 hours ahead of time.Dysphagia: yes.Chronic cough: yes.Sore throat: no.Voice changes: yes, hoarseness.Worsening asthma: no.Pneumonia: no.Response to medical therapy: taking prilosec then switched two years ago due to stop working.Now taking protonix 20mg po qd (when stopped protonix her abdominal discomfort improved).Adds zantac at night 3 times/week.Egd with dilation and ugi, pt has received results.Did they have an autoimmune disease? no.Has the patient been prescribed medication? yes, if yes, why was the medication prescribed? esophageal spasm, gerd, nausea was the medication prescribed to treat the dysphagia, gerd, etc.Yes.Were they taking this medication prior to implant ? no.Are they currently taking steroids / immunization drugs? no.The patient had the device explanted yesterday ((b)(6) 2019).

Event Description

It was reported that, ¿linx device implanted in (b)(6) of 2017.The patient has linx device that is part of recall.Patient had dysphagia and ¿pooling¿ according to her.Couldn¿t determine if device was discontinued as subject to the recall.Next steps to be determined, but surgeon intends on explanting the device on a date tbd.

Manufacturer Narrative

(b)(4).Date sent: 05/21/2020.Additional information received: ethicon consulting surgeon was able to speak with dr.(b)(6) and his summary is as follows: the patient was implanted several years ago and initially did well.She had issues with dysphagia and underwent several dilations that intermittently helped.After a couple of years, the patient continued to complain of dysphagia and after the patient was alerted to the recall, she wanted the device removed.Intriguingly, he notes that a second break in the linking wires was noted during removal.It appears there was confusion on his part as to the potential manufacturing issue that resulted in the recall notice.When i informed him of the true root cause, and he confirmed that he saw nothing suggestive of recall issue at the time of his explantation.

Manufacturer Narrative

(b)(4).Date sent: 04/23/2020.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9395122
• MDR Text Key: 168634828
• Report Number: 3008766073-2019-00548
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2020
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 11366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 04/07/2020; 05/06/2020
• Supplement Dates FDA Received: 04/23/2020; 05/21/2020
• Patient Sequence Number: 1
• Patient Age: 64 YR