MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vomiting (2144)

Event Date 12/09/2021

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.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: what is the lot #? is the patient currently taking currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? were there any intra-operative complications during implant? were there any other contributing factors that led to the removal of the device other than the reported vomiting? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the device was explanted from patient on (b)(6) 2021 due to the patient experiencing a lot of vomiting.Device was implanted (b)(6) 2021.

Manufacturer Narrative

(b)(4).Date sent: 1/13/2022.Additional information was requested, and the following was obtained: what is the lot #? 26977.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? yes.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? yes.When using the linx sizing device what technique was used to determine the size? pop plus 2 or 3.Did the patient have an autoimmune disease? no.Were there any intra-operative complications during implant? no.Were there any other contributing factors that led to the removal of the device other than the reported vomiting? no.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.

Manufacturer Narrative

(b)(4).Date sent: 02/09/2022.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.No further investigation will be conducted on this complaint as the device is found to meet the specifications.Overall, no analysis conclusions relevant to the patient experience were found.A manufacturing record evaluation was performed for the finished device batch number 26977, and no non-conformances were identified.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13087252
• MDR Text Key: 282772019
• Report Number: 3008766073-2021-00267
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2022

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: 04/21/2024
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 26977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 12/27/2021; 01/12/2022
• Supplement Dates FDA Received: 01/13/2022; 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention