MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Model Number LXMC16

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

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pain (1994); Rash (2033); Hernia (2240); Abdominal Distention (2601); Weight Changes (2607)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that the patient had severe epi-gastric pain, food getting stuck occasionally.Symptoms post implant of linx device lxmc16.Device remains implanted.¿.

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2021.Health effect - clinical code: generalized disorders (e23).No lot number was provided therefore a device history could not be done.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: please confirm the lot number.Additional information received: patient is s/p s/p laparoscopic repair paraesophageal hernia with linx size 16/open umbilical hernia repair on (b)(6) 2021.He describes pain that goes from his chest to his neck occurring once a month every other month.The pain was so intense that he has been to the ed and had a cardiac work-up.Pre-op: egd/bravo: 5cm hiatal hernia; demeester 46.3; normal motility.Reflux for 20+ years took omeprazole 40mg with break through symptoms including night time regurgitation post-op: on (b)(6) 2021-offce visit- patient was in the ed, then seen in the office same day for dysphagia after eating the last bite of grits (too dry).He was treated with steroids at the hospital and then was able to drink liquids.Prescribed prednisone 20mg x 7 days for dysphagia and rash.On (b)(6) 2021-telephone- rash subsided, bp normalized, and dysphagia had improved.He had 3 incidents of dysphagia since the previous visit and worked through them all.He lost 12 lbs.Canceled his follow-up as he contracted covid.(b)(6) 2022, called w complaint a donut got stuck- otherwise all was well on (b)(6) 2022, office visit- woke at 3am and belched, felt the sharp 2-sided dagger pain that went up to the throat area, continued with deep breaths for 15 minutes.No reflux, regurgitation or nausea since the surgery.Prescribed levsin 0.125mg tid.On (b)(6) 2022- patient in the ed for similar atypical chest pain heart catheterization was negative.Elevated bp increased hydrochlorothiazide and added lisinopril.Image studies done 1 day apart read by 2 different radiologists, ordered by gi: on (b)(6) 2023, barium swallow.Small hiatal hernia with minimal reflux in the distal third of the esophagus.On (b)(6) 2023, upper gi series w kub.Normal.Reflux device present without reflux noted during the exam.On (b)(6) 2023- office visit- patient continues to be challenged once every other month with pain going from his chest to his neck.Encouraged the patient to eat smaller more frequent meals, sitting upright, avoid late night eating.Prescribed gabapentin 100mg tid.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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: 5/1/2023.Additional information was requested, and the following was obtained: when this file was first reported it had the attached information concerning the linx lxmc16.Lot unk.Procedure date implant date: (b)(6) 2021.With the information below it was stated: explant date: (b)(6) /2023 lot #: 21746.Model: lxmc15.Implant date: (b)(6) 2018.Please confirm which information is correct.Answer - for this patient the device was a lxmc16.Implanted on (b)(6) 2021 and has not had it explanted yet.The lot number is 26704.The patient utilized gabapentin with relief with no reflux.A manufacturing record evaluation was performed for the finished device lot number 26704, and no related nonconformances were identified.B1, b2, h1 file has now been returned to a malfunction file.6.Health effect - impact code f19.There was no surgical intervention.

Manufacturer Narrative

(b)(4); date sent: 4/5/2023.D6b: the device has been explanted but the exact date is unknown.Follow up questions have been sent but there was discrepancies in the answers.Additional information was requested, and the following was obtained: when was the explant date? what is the lot number? answer : explant date: (b)(4) 2023.Lot #: 21746.Model: lxmc15.Implant date: (b)(6) 2018.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: there are a lot of discrepancies in this file and we need to confirm that we are all talking about the same file.When this file was first reported it had the attached information concerning the linx lxmc16; lot unk; procedure date implant date: (b)(6) 2021.With the information below it was stated: explant date: (b)(6) 2023; lot #: 21746; model: lxmc15; implant date: (b)(6) 2018.Please confirm which information is correct.B1, b2, h1 file is now a serious injury file.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16385857
• MDR Text Key: 309686114
• Report Number: 3008766073-2023-00026
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2023

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: 02/20/2024
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Device Lot Number: LOT 26704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/23/2023; 04/26/2023
• Supplement Dates FDA Received: 04/05/2023; 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male