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

Model Number LXMC13

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Pain (1994); Vomiting (2144); Abdominal Distention (2601)

Event Date 09/14/2017

Event Type  Injury  

Event Description

It was reported that post-op to the linx procedure that the device is disconnected and can be seen through the x-ray.An mri is being completed.Patient is in a lot of pain and wants the device taken out immediately.

Manufacturer Narrative

(b)(4).Date sent: 4/26/2023.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information received: the patient is having many symptoms including upper rt center abdomen pain, bloating, acid sensation with burning in the throat, still undergoing testing to determine the cause.X-ray showed the linx is discontinuous (come undone).Mri of the abdomen & pelvis, to check biliary ductal dilatation and choledocholithiasis was rescheduled.Unfortunately, imaging was limited by blooming from the linx and the visualizations are not clear.Have asked for a retest if there is a better way to obtain clearer pictures or for a ct as recommended by the radiologist.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: do we have permission to reach out to your surgeon to ask the below questions? if yes, what is the surgeons name with contact information? when we reach out to the surgeon, they will ask for you date of birth, what is your date of birth? the below questions will be sent to your surgeon: what symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: (b)(4).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.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? why was the mri being done on sunday (b)(6) 2023? what were the results of the mri if it is related to the linx? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 5/16/2023.Additional information received: i am just concerned about my health and quality of life.Which was great before the linx went undone or discontinuous.I have unusual pain.Bending, sitting, stretching, drinking, just about anything i do.Can you give any idea what i can do.My linx implant has worked great for me for 5 + years.Never had to take any medications.Once in a while i would choke, vomit, or gag on food.Since on (b)(6) 2022 i started choking, gagging, and vomiting every couple days.It was so bad i could hardly breathe.Had to wait a month or so to see a doctor so i had to do something.I went a on a soft diet, it was hard.I made sure i cut all my food up into very small pieces.It helped some on the heartburn.Now! i am having many symptoms including center upper abdomen pain, bloating, acid sensation with burning in throat.I am still undergoing testing to determine the cause.My x-ray showed the linx is discontinuous (come undone), which is why i contacted you.I am interested to know if the state of the linx should be concerning.My mri wednesday on (b)(6) 2023 was completed.Unfortunately, imaging was limited by blooming from the device and the visualizations are not clear.I have asked for a retest if there is a better way to obtain clearer pictures or for a ct as recommended by the radiologist.A manufacturing record evaluation was performed for the finished device lot number: 14605, and no related nonconformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 5/26/2023.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16815039
• MDR Text Key: 314005826
• Report Number: 3008766073-2023-00074
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2021
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 14615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/05/2023; 05/26/2023
• Supplement Dates FDA Received: 05/16/2023; 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention