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 Problems Dysphagia/ Odynophagia (1815); Pain (1994); Burning Sensation (2146); No Code Available (3191)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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 #? what symptoms did the patient have that made them unhappy that was not related to the reported event? 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? was mesh used at time of 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?.

Event Description

It was reported that a linx device was explanted on (b)(6) 2020 because the 'patient was unhappy and couldn't drink wine fast enough.'.

Manufacturer Narrative

(b)(4).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.The dhr for lot 22983 was reviewed.No defects, reworks, or ncs related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 07/20/2020.Additional information was requested, and the following was received: what is the lot #? 22983.What symptoms did the patient have that made them unhappy that was not related to the reported event? the patient had difficulty adjusting to the device.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? throat pain, burning and coughing.Was there any hiatal or crural repair done at the same time as the implant? yes.Was mesh used at time of implant? no mesh was used at the time of implant.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? no, the patient is still experiencing dysphagia although it appears to be more pharyngeal as patient is concerned about aspiration.

• 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: 10179259
• MDR Text Key: 196446533
• Report Number: 3008766073-2020-00082
• 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,Followup
• Report Date: 06/03/2020

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: 06/20/2022
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 06/24/2020; 07/23/2020
• Supplement Dates FDA Received: 07/20/2020; 07/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention