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

Catalog Number LXMC16

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

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date sent: 3/26/2024.D6a: exact implant date is unk.Assumed 1st month of the year and 1st day of the month.B3: unknown; captured as awareness date.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device 24189 number, and no non-conformances related to the malfunction were identified.Additional information was requested, and the following was obtained: what was the date of implant? january 2020.Why was the mri being performed? unrelated to implant.Ordered by base doctor.What symptoms lead to mri being taken? headaches & memory concerns.When did they begin? unknown.Was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? none at the time of surgery.Forced vomiting is sometimes required if i'm having issues swallowing.When was the mri taken? early 2023.I deployed shortly afterwards so i never went in for another mri.What was the mri strength? unknown at this time but i was told it was within the safe range for linx.Did the patient have any other surgeries in the area? no.What is the management plan? quut eating for a few minutes when experiencing difficulties swallowing.Sometimes i take carafate liquid to ease symptoms.Is device removal scheduled? no.Although some symptoms have returned since the mri, overall my quality of life is still better today than it was prior to the linx implant.Is a replacement linx or fundoplication planned? no.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 a patient had a linx installed (b)(6) 2020 at hospital in san antonio, tx.Patient recently had a bad experience in an mri where an intense static electricity type shock was shot through their chest, accompanied by a painful feeling patient can only describe as an intense energy wave that bounced/pulled in different directions in their chest.The experience started almost immediately when the machine spun up and ended quickly when patient pushed the emergency stop button.It was followed by an intense period of nausea.The device still works but patient sometimes experience minor reflux now which had not happened since installing the device.The mri technicians said the machine was rated for 1.5t.

• 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 ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 18978346
• MDR Text Key: 338595427
• Report Number: 3008766073-2024-00049
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: LXMC16
• Device Lot Number: 24189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• 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