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

Catalog 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 Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Vomiting (2144); Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that on a recent barium swallow, the linx is disrupted, the patient has reoccurring unknown symptoms.That was all that was available at the time of the call.

Manufacturer Narrative

(b)(4).Date sent 12/1/2023 b3: only event year known: 2023.No lot number was provided therefore a device history could not be done.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: was the device explanted on (b)(6) 2023? if no, when was the device explanted? what is ¿the patient has reoccurring unknown symptoms¿? what were the symptoms? 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? additional information provided: if the device is discontinuous or eroded, can you please send photos to productcomplaint1@its.Jnj.Com.If the patient received an mri while the linx was implanted what was the tesla strength of the mri? 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: 12/19/2023.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.Additional information was requested, and the following was obtained: was the device explanted on (b)(6) 2023? explant is planned for (b)(6) 24.If no, when was the device explanted? see above.What is ¿the patient has reoccurring unknown symptoms¿? what were the symptoms? yes-cough/regurgitation, dysphagia.What symptoms lead to the discovery of the discontinuous device? when did they begin? yes-cough/regurgitation, dysphagia; >1 year ago.What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: productcompliant1@its.Jnj.Com (b)(6) 22.What is the device lot number? lxmc14 - log440029.Was the device initially effective in controlling reflux? improved but did not resolve cough.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? no.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? not to my knowledge.Did the patient have any other surgeries in the area? no.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.Device placed in 2018 and as of 2020 barium swallow showed intact device.No imaging in 2021.Barium swallow in 2022 and 2023 show discontinuous device.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? device removal with replacement with linx.When and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? unable to record with current or equipment when and if the linx device is removed, may we ask that the device be returned for analysis? yes.

Manufacturer Narrative

(b)(4).Date sent: 1/16/2024.Additional information received.The device was removed on 1/5/2024.Photo analysis: an x-ray image of the device in vivo was reviewed by a medical safety officer.As per medical safety officer: "the barium esophagram reviewed demonstrates a linx device located below the diaphragm that is discontinuous, and dilated esophagus." the mechanism/cause of failure is unknown as a hands-on analysis of the device is necessary to determine the cause of failure.No further investigation can be completed at this point.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18248631
• MDR Text Key: 329550117
• Report Number: 3008766073-2023-00239
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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,Followup,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2024
• 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