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

Model Number	LXMC13
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 6/26/2023.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.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 or Problem Description
It was reported that dr.(b)(6) saw a patient who had a linx implanted years ago and is having very bad dysphasia and needs to have the links removed.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/17/2023.D6a: exact implant date is unk.Assumed first day of the month.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? not sure; placement was done by dr.(b)(6).What was the date of implant? on (b)(6) 2013.What size device was used? size 13.When using the linx sizing device what technique was used to determine the size? trying to find the op note again is a pain in the butt, not sure.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunosuppressive drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.How severe was the dysphagia/odynophagia before intervention? no dysphagia prior to linx placement.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? don't think so, but would need to triple check.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia, vomiting and weight loss? no.Besides the reported dysphagia, vomiting and weight loss what was the reason for removal of the linx device? just the above.Was the device found in the correct position/geometry at the time of removal tbd.Additional information received: i spoke with (b)(6) earlier this week, dr.(b)(6) surgery scheduler re: a patient requiring removal¿planning surgery for on (b)(6).Additional information was requested, and the following was obtained: did the linx get removed on (b)(6)? if no, why not? is there another surgery date planned? if yes, when is the surgery date planned? answer : the linx did indeed get removed on (b)(6).

• Brand Name: 1.5T LINX, 13B
• Common Device Name: 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: 17198018
• Report Number: 3008766073-2023-00115
• Device Sequence Number: 5683905
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female