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); No Code Available (3191)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the manufacturing records evaluation could not be performed.Additional information received: on what date did the implant take place? (b)(6) 2019.Lot #? unknown.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? yes.Was mesh used at time of implant? unknown.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? unknown.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that the linx was removed at patient's request due to dysphagia.

• Brand Name: 1.5T LINX, 13B
• 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, MN ; 6107428552
• MDR Report Key: 10158195
• MDR Text Key: 195261710
• Report Number: 3008766073-2020-00079
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 05/27/2020

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: LXMC13
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention