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

Catalog Number LXMC13

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pyrosis/Heartburn (1883); Pocket Erosion (2013)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 2/22/2024.B3: unknown; captured as awareness date.No lot number was provided therefore a device history could not be done.Additional information received: the implant was done in texas and the patient now lives in pa.He has been seeing dr.(b)(6) hospital.(b)(6).Dob is (b)(6) 1959.The patient did mention that since the discovery of the eroded device that his gerds have returned slightly but not horrible.He is taking otc meds to help.At this time the patient does not want the device removed but i let him know the pc# so if the device is ever removed that he can let us know.What is the product code? lxmc13.What was the date of implant? (b)(6) 2017.What were the first clinical symptoms that provided evidence of an erosion and when did they first occur? gerds returning.Has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.Egd in may 2023, xray in 2023 showed slippage of linx and erosion of the stomach.No bowel obstruction.No recurrent hiatal hernia.Are pictures or videos available? not available.How many beads eroded? where were the eroded beads positioned? was the patient stented? what is the current condition of the patient? in good condition but just has a little gerds how was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? x-ray.Are there images available that shows the migration? not available.Did the patient have a hiatal hernia at the time of implant? if yes was this repaired at this time of implant? yes.Does the patient have a re-occurring hernia now? if yes, did the position of the device change based on the hernia reoccurring? no re-occurring hernia.The report that kelly was reading stated ¿slippage of linx, erosion into the stomach, no recurrent hh, no bowel obstruction.Could not get her to send me the report.I asked that if and when the device is removed that ethicon be notified and gave pc # patient in er has a linx device free floating in abdomen.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.

Event Description

It was reported that a linx device has migrated and eroded and is on the stomach now, there is a shoulder issue that needs an mri.

• 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 ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 18761605
• MDR Text Key: 336054870
• Report Number: 3008766073-2024-00039
• Device Sequence Number: 1
• Product Code: LEI
• 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
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• 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
• Patient Age: 64 YR
• Patient Sex: Male