MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS14; ANTI-REFLUX IMPLANT

Catalog Number LS14

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent:12/13/2023.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: on what date did the implant take place? on what date did the explant take place? lot #? does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? what was the reason for removal of the linx device? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? 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

The device was received without event details.No patient consequence reported.

Manufacturer Narrative

(b)(4).Date sent: 1/31/2024.Investigation summary: overall review of the device function and dimensions show no anomalies from a device that was returned for analysis.Visual analysis was consistent with an explanted device, and significant tooling marks were noted in some beads.Link length and tensile force were found to meet the applicable specifications.Overall, the device was found to be conforming.

Manufacturer Narrative

(b)(4); date sent: 1/2/2024.Additional information received: the product code is ls14.Additional information was requested, and the following was obtained: on what date did the implant take place? on what date did the explant take place? lot #? does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? what was the reason for removal of the linx device? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? answer: no more additional information available.

• Brand Name: LS14
• 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: 18318236
• MDR Text Key: 330379921
• Report Number: 3008766073-2023-00252
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005035
• UDI-Public: 00855106005035
• 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: 01/31/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: LS14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 01/31/2024
• Supplement Dates FDA Received: 01/02/2024; 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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