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

Model Number LXMC14

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/24/2020.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.Additional information was requested, and the following was obtained: lot number: 21198.Does the patient have any of the allergies to metals? no.Is the patient currently taking currently taking steroids/ immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.Was there any hiatal or crural repair done at the same time as the implant? no.Was mesh used at time of implant? no.What was the reason for removal of the linx device? the patient has been having discomfort and difficulty swallowing and wanted it removed.At the time of removal, was the device found in the correct position/geometry at the time of removal? yes.Have the symptoms resolved since the device was explanted? patient has a lap toupet fundoplication at the time the linx was explanted.

Event Description

It was reported that a linx device was explanted on (b)(6) 2020 for unknown reasons.

Manufacturer Narrative

(b)(4).Date sent: 08/27/2020.The dhr for lot 21198 was reviewed.No ncs, defects, or reworks related to the product complaint were found.To date no device has been returned.

Manufacturer Narrative

(b)(4).Date sent: 10/6/2020.Device analysis: the visual analysis was consistent with an explanted device.The device was returned in two segments with a cut wire.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.

• 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: 10442542
• MDR Text Key: 204438639
• Report Number: 3008766073-2020-00128
• 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
• Type of Report: Initial,Followup,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 Expiration Date: 05/29/2022
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 21198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/27/2020; 09/17/2020
• Supplement Dates FDA Received: 08/27/2020; 10/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention