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

Catalog Number UNK LINX MAGNETIC IMPLANT

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

Patient Problems Pyrosis/Heartburn (1883); Hernia (2240)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent; 3/7/2024 d6a: exact date is unk.Assumed first month of the year and first day of the month.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 received: patient was implanted in 2017 by (b)(6), developed reflux again a "few years ago" and now decided to have it removed.Patient stayed 2 days after the removal, not linx related.Surgeon removed the linx, repaired a hiatal hernia and then did a partial fundoplication (toupet).Case was done with the davinci robot and took about 3 hours.The device was cut on the wire to be removed.Surgeon didn't experience any abnormal issues or have any complaints during the surgery.Additional information was requested, and the following was obtained: what was the exact date of the implant? - exact date unknown, implanted in 2017 by dr isch what is the product code? - unknown what is the lot number for the linx device? - unknown was ph testing performed prior to explant to confirm recurrent reflux? - no after implant, was the device initially effective in controlling reflux? - yes was there any hiatal or crural repair done at the same time as the implant? - unknown was mesh used at time of implant? - unknown does the surgeon believe that the recurrent hernia was the cause of the recurrent gerds? - i didn't ask that question, i will update if i get a response.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 the surgeon alerted me that she performed a surgical explant of a linx device.

Manufacturer Narrative

(b)(4).Date sent: 3/15/2024.Additional information was requested, and the following was obtained: does the surgeon believe that the recurrent hernia was the cause of the recurrent gerds? - she was not sure, the linx device "looked as it should".

• 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: 18856268
• MDR Text Key: 337109007
• Report Number: 3008766073-2024-00046
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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
• Date Manufacturer Received: 02/20/2024
• 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