MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Event Description

It was reported that the linx seemed to be dislodged in the patient.Surgeon feels the titanium chain broke on it after using an x-ray.The linx was implanted in 2016.

Manufacturer Narrative

Date sent: 4/10/2024.B3: only event year known: 2024.D6a: exact implant date is unk.Assumed 1st day of the month and 1st month of the year.No lot or batch number was provided therefore a device history could not be done.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.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: 4/26/2024.Additional information received: patient is 70 year old female that had a linx procedure in 2017.Surgeon saw patient in office and linx device seems to be dislodged by the titanium wire confirmed not to be clasp by upper gastric xray.The titanium band did not break because of an xray.Patient recovered form linx procedure and was doing well.Symptoms slightly returned.Surgeon is planning to remove device.

Manufacturer Narrative

(b)(4).Date sent: 5/2/2024.Additional information was requested, and the following was obtained: when you mentioned ¿symptoms slightly returned¿ what symptoms are you referring to? did the patient have an mri and if yes what was the strength? what was the exact date of implant? what symptoms lead to the discovery of the discontinuous device? when did they 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 what is the product code? what is the device lot number? 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? answer: i haven¿t been able to gather specific device information.The surgeon is planning on removing the device and i will be in attendance to ensure the device is sent in for analysis.Dr.(b)(6) did mention that the device was successful in provide relief for gerd diagnosis.Up until the patient returned that is when they discovered the device was broken.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• 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: 19078979
• MDR Text Key: 339815725
• Report Number: 3008766073-2024-00059
• Device Sequence Number: 1
• Product Code: LEI
• 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: 05/02/2024

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/24/2024; 05/02/2024
• Supplement Dates FDA Received: 04/26/2024; 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 70 YR
• Patient Sex: Female