MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Model Number LXMC15

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pneumonia (2011)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown; captured as awareness date.The dhr for lot 14054 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.Lot 14054 was an affected lot of the 2018 linx recall.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: what was the date of implant? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant?.

Event Description

It was reported that the patient had a chest x-ray for pneumonia, incidental finding of discontinuous linx.Patient complaining of increased gerd symptoms and dysphagia over last 4 months.Scheduled for egd (b)(6) 2021 and will go from there.No other information available.

Manufacturer Narrative

(b)(4).Date sent: 6/10/2021.Additional information was requested, and the following was obtained: implant date: (b)(6) 2017.The onset of symptoms: (b)(6) 2021.Dysphagia and gerd ; prior to that almost asymptomatic.Did very well after surgery.Off ppi.Nearly symptom free of dysphagia.No gerd.No mri nor trauma.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11820592
• MDR Text Key: 261267968
• Report Number: 3008766073-2021-00093
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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
• Report Date: 04/28/2021

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: 02/27/2021
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 14054
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention