MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Model Number LXMC13

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: lot #? ¿ unknown.When using the linx sizing device what technique was used to determine the size? unknown.Did the patient have an autoimmune disease? - no.Is the patient currently taking steroids / immunization drugs? - unknown.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? - unknown.How severe was the dysphagia/odynophagia before intervention? - none.Were there any intra-operative complications during implant? - no.Was there any hiatal or crural repair done at the same time as the implant? - yes were there any other contributing factors that led to the removal of the device other than the reported dysphagia? ¿ no.What was the reason for removal of the linx device? ¿ patient felt like the device was ¿broken¿.Xrays showed it was still intact.Was the device found in the correct position/geometry at the time of removal? - yes.Was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? please share any additional images.- unknown.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that the patient had the lxmc13 implanted on (b)(6) 2019 for problems with gerd and a hiatal hernia repair.Since that time the patient felt like the device was broken and wanted it removed.X-rays indicated that the device was still in tact.The device was explanted on (b)(6) 2020.

Manufacturer Narrative

(b)(4).Date sent: 09/10/2020.Device analysis: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The lot / batch was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10442424
• MDR Text Key: 207332085
• Report Number: 3008766073-2020-00126
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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 Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention