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

Catalog Number LXMC16

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

Patient Problem Pain (1994)

Event Date 09/27/2023

Event Type  Injury  

Event Description

It was reported that a patient who had a linx device placed in 2018, last week patient heard a snap in his chest followed by pain and x ray showed the device is broken.The device is still implanted.

Manufacturer Narrative

(b)(4).Date sent: 10/5/2023.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of 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: when did the 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: productcompliant1@its.Jnj.Com was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when 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? 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)(6).Date sent: 10/30/2023.Additional information received: replaced with lxmc17 lot# 27013 exp 4/27/24 which was implanted on (b)(6) 2023 on the day of the explant as the patient requested a new implant.Additional information was requested, and the following was obtained: when did the symptoms begin? (b)(6) 2023 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 9/22/2023 chest x ray and chest ct done at catholic medical center manchester, nh.I¿m not sure how to send these images via email given they are from an outside facility.Was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? pt reports feeling a ¿snap¿ while carrying a ladder with acute onset of chest pain, exacerbated with deep breaths.Did the patient undergo an mri since device implant? yes.4 based on our records.If so, when was the mri and what strength? (b)(6) 2019 cervical spine, (b)(6) 2019 l shoulder, (b)(6) 2021 brain, (b)(6) 2021 cervical spine.These were all done at dartmouth in manchester.I have a message out to them regarding the strength did the patient have any other surgeries in the area? 2 egd¿s.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.(b)(6) 2019 l shoulder xray, (b)(6) 2019 l shoulder injection with fluoroscopy, (b)(6) 2019 ugi with food, (b)(6) 2019 egd w/dilation, (b)(6) 2020 chest x ray & cervical spine ct.Device in place/not visible based on image locations or in place at time of all above imaging.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? device removed (b)(6) 2023.Pt would like replacement.

Manufacturer Narrative

(b)(4).Date sent: 11/20/2023.

Manufacturer Narrative

(b)(4).Investigation summary: a linx device with a visible weld ball that disconnected from 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 ball, show no anomalies for a device that has been reasonably changed as part of the explant procedure, tooling marks were noted in some beads.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The male bead case through-hole at the separation was measured and was greater than the specification.The male bead case through-hole was concentric with small amount of material displacement at the outer edge of the through-hole.The overall appearance of the surface of the male bead case through hole didn¿t exhibit gross 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.A manufacturing record evaluation was performed for the finished device 20677 number, and no non-conformances related to the malfunction were identified.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17876360
• MDR Text Key: 324984165
• Report Number: 3008766073-2023-00203
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2022
• Device Catalogue Number: LXMC16
• Device Lot Number: 20677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention