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

Catalog Number LXM13

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Weight Changes (2607)

Event Date 07/24/2023

Event Type  Injury  

Event Description

It was reported that the patient had a linx in situ for approximately five years.Implanted in london.The surgeon reports patient had issues since insertion and many dilatations.The patient presented very malnourished, bmi 16, the device was surgically removed.The device had migrated up the oesophagus into the chest¿lots of adhesions surrounding the linx.Tpn for five days post for malnourishment.The patient received a revision and removal of device.

Manufacturer Narrative

(b)(4).Date sent: 8/10/2023.D6a: exact date unk.Assumed first day of the month and first month of the year.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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: how was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? are there images available that shows the migration? did the patient have a hiatal hernia at the time of implant? if yes was this repaired at this time of implant? does the patient have a re-occurring hernia now? if yes, did the position of the device change based on the hernia reoccurring? what was the exact implant date? what is the lot number of the device? 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).Additional information was requested, and the following was obtained: how was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? explant are there images available that shows the migration? not available.Rep doesn't have any new information to report on this case.

• Brand Name: LINX 1.5T 13 BEAD OUS
• 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: 17498562
• MDR Text Key: 320914494
• Report Number: 3008766073-2023-00163
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXM13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2023
• 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
• Patient Sex: Male