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

Catalog Number LXMC15

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); No Code Available (3191)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 08/03/2020.The dhr for lot 15608 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: on what date did the implant take place? (b)(6) 2017.Lot # of the linx? 15608.Does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.No metal allergy.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 ¿ nissen takedown with dissection and partial gastrectomy were completed with linx implant.Was mesh used at time of implant? no.What was the reason for removal of the linx device? dysphagia and sensation of heartburn.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 ¿ although this is early.

Event Description

It was reported that a patient had a linx explant performed on (b)(6) 2020.

Manufacturer Narrative

(b)(4).Date sent: 08/26/2020.Additional information received: the product code is lxmc15.A suture was placed around the linx device to aid with extraction as it was extracted through one of the port sites.Fifteen beads were again counted once the device was outside of the body consistent with the size that was placed at her original operation.Device analysis: a knotted suture on a wire adjacent to one of the clasp beads was observed during the visual assessment.Per additional information received, the suture was placed during the explant procedure to aid with the explant of the device.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 dhr for lot 15608 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Mfg date: 30/jun/2017; exp date: 30/jun/2021.

• 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: 10356776
• MDR Text Key: 201690134
• Report Number: 3008766073-2020-00112
• Device Sequence Number: 1
• Product Code: LEI
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: LXMC15
• Device Lot Number: 15608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 08/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention