MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 16 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM16

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Diarrhea (1811); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 5/16/2023.B3: unknown; captured as awareness date.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: on what date did the implant take place? unknown.On what date did the explant take place? 2nd may.What is the product code? lxm(unknown number).Lot #? not known.Does the patient have any of the allergies to metals? no.Is the patient currently taking currently taking steroids / immunosuppressive drugs? unknown.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? unknown.Was there any hiatal or crural repair done at the same time as the implant? unknown was mesh used at time of implant? unknown.What was the reason for removal of the linx device? patient experience upset stomach, loose soft stool, which was paler, chest spasms, pain across the upper abdomen and going up into a chest and neck.At the time of removal, was the device found in the correct position/geometry at the time of removal? yes.Have the symptoms resolved since the device was explanted? unknown.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 there was a removal of a linx device.No further info available.

Manufacturer Narrative

(b)(4).Date sent: 7/19/2023.

Manufacturer Narrative

(b)(4).Date sent: 7/24/2023.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, some tooling marks were observed 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: LINX 1.5T 16 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16938712
• MDR Text Key: 315292694
• Report Number: 3008766073-2023-00082
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2023

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: LXM16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 07/10/2023; 07/24/2023
• Supplement Dates FDA Received: 07/19/2023; 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention