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

Model Number LXMC16

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 6/5/2020.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.The following information was requested, but unavailable: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? on what date did the implant take place? what is the lot number of the linx device? 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? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? was the device found in the correct position/geometry at the time of removal?.

Event Description

It was reported that post implant of a linx device an explant of lxmc16 due to dysphagia was performed.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 07/16/2020.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.

Manufacturer Narrative

(b)(4).Date sent: 07/10/2020.Additional information was requested, and the following was received: no further information on this compliant.

• 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
• MDR Report Key: 10122861
• MDR Text Key: 194779527
• Report Number: 3008766073-2020-00073
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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,Followup
• Report Date: 05/14/2020

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: LXMC16
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/15/2020; 07/14/2020
• Supplement Dates FDA Received: 07/10/2020; 07/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention