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

Model Number LXMC13

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pyrosis/Heartburn (1883); Pain (1994)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that a linx device was removed and it appeared to be broken in a couple of places.The patient reported he had an mri and experienced chest pain.The patient¿s gerds symptoms came back after the mri.No further details at this time.

Manufacturer Narrative

(b)(4).Date sent: 3/16/2023.Only event year known: 2023.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.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: what was the date of implant? what was the explant date? what is the product code? what is the lot number for the linx device? was ph testing performed prior to explant to confirm recurrent reflux? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin? when did the gerds symptoms begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: (b)(4).Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? what was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? 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).Date sent: 3/30/2023.Additional information was requested, and the following was obtained: what was the date of implant? what was the explant date? what is the product code? what is the lot number for the linx device? was ph testing performed prior to explant to confirm recurrent reflux? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin? when did the gerds symptoms begin? what was the date of the imaging which showed the discontinuous linx? if available, was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? what was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? answer - model# lxmc13.Lot# 9401.Implant date: (b)(6) 2015.Explant date: (b)(6) 2023.Onset of symptoms: (b)(6) 2022 during mri.Mri date: (b)(6) 2022.Mri strength: 1.5 tesla.Patient gender: female.Patient age: 69.Bmi: 22.6.General health: good.Allergies: sulfa, tetracycline, niacin.D1, d4.

Manufacturer Narrative

(b)(4).Investigation summary: a linx device with two visible weld balls disconnected from a washer and a male bead case was returned to the analysis site.The link length and tensile force measurements were found to meet the applicable specifications during device analysis.The remaining device characteristics, excepting the visible weld balls, show no anomalies for a device that has been reasonably changed as part of the explant procedure.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.Both through-holes at the separation were measured and was greater than the specification.The through-holes were concentric with material displacement at the outer edge of the through holes.The overall appearance of the surface of the washer and male bead case didn't exhibit loss of shape.The washer was observed to be bent outwards with both welds holding in place.The top view of the diameter of the exposed weld balls were measured.This diameter is within the specification.The weld balls were concentric with the respect to the wire.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances related to the malfunction were identified.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16552878
• MDR Text Key: 311393820
• Report Number: 3008766073-2023-00045
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2019
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 9401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/20/2023; 02/28/2024
• Supplement Dates FDA Received: 03/30/2023; 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female