MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number LXMC14

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Pyrosis/Heartburn (1883); Hernia (2240); Insufficient Information (4580)

Event Date 11/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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 was explanted due to the device being discontinuous.Unknown if another device was implanted.Unknown as to how the discontinuous device was found.No further information was provided.

Manufacturer Narrative

(b)(4).Date sent: 2/7/2023.Additional information was requested, and the following was obtained: what was the date of implant? (b)(6) 2016.What was the date of the explant? - (b)(6) 2022.What symptoms lead to the discovery of the discontinuous device? when did they begin? - returned reflux-(b)(6) 2021.What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: productcompliant1@its.Jnj.Com - n/available.Was the device initially effective in controlling reflux? - yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? - not reported.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? - yes, magnet strength unknown.Did the patient have any other surgeries in the area? - none reported.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.- cxr in (b)(6) 2020 with no disruption reported.Is a replacement linx or fundoplication planned? - no.

Manufacturer Narrative

(b)(4).Date sent 8/15/2023.Investigation summary: a linx device with a visible weld ball that disconnected from a washer 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 ball, show no anomalies for a device that has been explanted.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The washer through-hole at the separation was measured and was greater than the specification.The washer through-hole was non-concentric with small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the washer through hole exhibits loss of shape.The top view of the diameter of the exposed weld ball was measured.This diameter is within the specification.The weld ball was concentric with the respect to the wire.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 1/9/2024.Investigation summary: a linx device with a visible weld ball that disconnected from a washer 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 ball, show no anomalies for a device that has been explanted.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The washer through-hole at the separation was measured which was greater than the specification.The washer through-hole was non-concentric with small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the washer through hole exhibits loss of shape.The top view of the diameter of the exposed weld ball was measured.This diameter is within the specification.The weld ball was concentric with the respect to the wire.

• Brand Name: 1.5T LINX, 14B
• 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, MN ; 3035526892
• MDR Report Key: 16214130
• MDR Text Key: 307779942
• Report Number: 3008766073-2023-00009
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2024
• 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
• Patient Sex: Male