MAUDE Adverse Event Report: TORAX MEDICAL INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Model Number LXMC15

Device Problems Device Appears to Trigger Rejection (1524); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Sepsis (2067); Vomiting (2144)

Event Date 02/13/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown; captured as awareness date.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.Additional information provided: patient has difficulty in getting some foods past the linx (had esophagus dilation several years ago followed by septicemia).Additional information was requested, and the following was obtained: what was the exact implant date? (b)(6) 2015.What was the tesla strength of the mri that was taken? i was told it was not over 1.7testa are there any additional inventions planned? not at this time.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 linx was implanted in their esophagus.They had an mri that caused significant pain in their abdomen and chest from the linx during the procedure.

Manufacturer Narrative

(b)(4).Date sent: 4/17/2023.A manufacturing record evaluation was performed for the finished device batch number: 8949 , and no non-conformances were identified.Additional information was requested, and the following was obtained: on (b)(6) 2015, linx surgery, (b)(6) clinic).The following is on the blue card: model no.Lxmc15, lot no.8949, ser no.(b)(6), toraxmedical.Com this model lis supposed to tolerate up to 170 tesla units with mri, but it did not.I had significant pain when an mri was performed on me.I need to speak with someone on the phone about this, because i am in need of having mri's performed on several parts of my body.Please confirm the strength of the mri that you underwent, as it is a bit unclear from the communications.The mri was run at 1.5t, below the max amount my linx band was supposed to tolerate.I had so much pain during my mri at 1.5t.

Manufacturer Narrative

(b)(4).Date sent: 6/27/2023.Additional information received: patient returned my call today and provided additional detail.He double checked with the mri facility and they confirmed the mri was 1.5 tesla.During the mri, he experienced severe pain in his lower chest and upper abdomen.The pain was so severe he almost stopped the mri and when it was over, the pain resolved within 15 seconds.He has joint health related problems and needs mri in the future.He¿s concerned that damage to his tissue may result and he doesn't want to have the device removed but will if this will continue to occur.He did undergo dilation after implant but doesn't remember exactly how long after implant.He does still get blockage 30 ¿ 40% of the time if he¿s not careful and this requires him to throw up at times to resolve it.He is hoping to get recommendations from us as to next steps.

Manufacturer Narrative

(b)(4).Date sent: 9/19/2023.Additional information received: call with patient was conducted by mso, (b)(4) and rm, (b)(4).Patient indicated he is typically a fast eater and experienced dysphagia after implant requiring dilation which helped.He still has difficulty swallowing on occasion but otherwise, has experienced good relief from gerd with the device.He had questions about mr conditions and an overview of the mr testing conducted on the linx device was provided by dr.(b)(4).He believes either his hip or knee was being examined during the mri where he experienced difficulty.He doesn¿t want to have the device removed at this time and plans to slow down when eating.Patient also asked about removal, if needed and otherwise had no other questions.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16452716
• MDR Text Key: 310346033
• Report Number: 3008766073-2023-00031
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: 09/19/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 8949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 04/03/2023; 06/22/2023; 09/18/2023
• Supplement Dates FDA Received: 04/17/2023; 06/27/2023; 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male