MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Model Number LXMC13

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot number was not provided; therefore, a manufacturing record 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: lot #? does the patient have any allergies to metals? if so, what tests have been done to test for metal allergies? 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? was mesh used at the time of implant? what was the reason for the removal of the linx device? 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? 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 linx was removed.No further information at this time.

• 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 55126 ; 6107428552
• MDR Report Key: 10995014
• MDR Text Key: 221236011
• Report Number: 3008766073-2020-00195
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention