MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number LXMC15

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Nausea (1970); Vomiting (2144); Dizziness (2194); Perforation of Esophagus (2399); Weight Changes (2607)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that the patient seen in january by neurologist due to severe dizziness, nausea, vomiting and weight loss.Also has had covid and other health issues (breast tumors) that have developed as well.Md doing more testing i.E.Parkinson disease.Md, used pop three and visual for sizing.Recent barium swallow shows poor motility.Md recommending explant due to patient¿s health status.

Manufacturer Narrative

(b)(4).Date sent: 9/18/2023.B3: only event year known: 2023.The device lot number is unknown; therefore, the device history record could not be reviewed.Additional information was requested, and the following was obtained: were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? please specify the symptoms the patient was experiencing prior to implant (gerd reflux, dysphagia, pain during eating, etc., )? had the patient had any diagnostic testing done to address the symptoms they experienced while the device was implanted? if yes, what diagnostic testing was completed? can you share the results of the diagnostic tests? do they have an autoimmune disease? has the patient been prescribed medication by a doctor (not over the counter medication)? if yes, what is the doctor prescribed medication? are they currently taking steroids / immunization drugs? answer: this is an update to the pc# above.It corresponds to a patient who was in need of a linx removal due to difficulty in swallowing, food getting stuck, associated weight loss.Diagnostic testing showed dysmotility and a dilated distal esophagus.The patient underwent device removal on (b)(6) 2023 at (b)(6) medical center, sarana lake ny and was discharged.On (b)(6) 2023, the patient presented at canton potsdam hospital, diagnosed with a perforated esophagus and was transferred to (b)(6) medical center, albany ny.No additional information is available.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).Investigation summary: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, tooling marks were observed in some beads, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 17763968
• MDR Text Key: 323590525
• Report Number: 3008766073-2023-00182
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

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 Catalogue Number: LXMC15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention