MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Model Number LXMC14

Device Problems Device Appears to Trigger Rejection (1524); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2022.No lot number was provided therefore a device history could not be done.Additional information received: spoke with patient who indicated her linx device was removed yesterday.Once she¿s more fully recovered, she will follow up with me and has my contact information.She believes the device is being returned to us.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 was the exact date of implant? what is the lot number (this should be on your implant card).What is the name of the facility that the device was explanted.Name and address please.For the remaining questions below we will need to reach out to your explant surgeon.Do we have permission to reach out to your surgeon? if yes, please provide the name and contact information of your surgeon.When we call your surgeon, they will want to know your date of birth, can you please provide your date of birth? questions for the surgeon: what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.What is the device lot number? was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.Is a replacement linx or fundoplication planned? when and if the linx device is removed, may we ask that the device be returned for analysis? if you have tried to get this information, but the account is unwilling to provide any additional information please let us know what you have done so we can document our report accordingly.Note body (local language).

Event Description

It was reported that she became symptomatic with persistent cough, dysphagia, and pain approximately sixty days ago.An endoscopy confirmed a discontinuous linx device.A follow up appointment to discuss next steps is scheduled in two weeks.

Manufacturer Narrative

(b)(4).Date sent: 4/12/2022.Upon review it was identified that this is a duplicate report of manufacturing report number 3008766073-2022-00063.Moving forward all additional information will be filed under 3008766073-2022-00063.Upon review it was identified that this is a duplicate report of manufacturing report number 3008766073-2022-00063.Moving forward all additional information will be filed under 3008766073-2022-00063.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: orla o'mahony ; 4188 lexington avenue north; shoreview 55126
• MDR Report Key: 13995251
• MDR Text Key: 290974377
• Report Number: 3008766073-2022-00070
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention