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

Catalog Number LXMC16

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 04/26/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date sent: 4/30/2024 b3: 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 was requested, and the following was obtained: on what date was the device implanted? (b)(6) 2017 on what date was the device explanted? still not explanted have you had any diagnostic testing done to address the symptoms you experienced while the device was implanted? if yes, what diagnostic testing were completed? i was told the device did into need to be removed as it was intact.No testing was done to check its functionality.My symptoms grew worse and i developed haital hernia can you share the results of the diagnostic tests? do you have an autoimmune disease? no have you been prescribed medication by a doctor (not over the counter medication)? yes if yes, what is the doctor prescribed medication? pantaprazole are you currently taking steroids / immunization drugs? 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 husband was calling about the linx compatibility with mri, but reports that his wife had 1.5t linx device implanted between 2015-2018 but never received any relief from her gerd symptoms.She was placed back on medication and never had evaluation of the device.She now has an appt with a surgeon to have nissen fundoplication procedure.Caller advised to have his wife see her surgeon to evaluate linx device and requested model and lot number to determine if her device was part of the recall and mri compatibility.On (b)(6) 2024 patient's husband responds to email with model and lot lxmc16 12721, which was included in the recall.

Manufacturer Narrative

(b)(4) date sent: 5/9/2024 additional information received: can you share the results of the diagnostic tests? the kaiser gastro surgeon who implanted the links was going to order a bravo test but we have not heard back so far.We are moving forward with manometry thru another insurance carrier.A manufacturing record evaluation was performed for the finished device 12721 number, and no non-conformances related to the malfunction were identified.

Manufacturer Narrative

(b)(4).Date sent: 5/15/2024.Additional information received: 67 year old female hiatal hernia.Images are not available for review.The radiology reports are consistent with a linx device located below the ge junction.There is no evidence of hiatal hernia.No comment about the device integrity is made.

• 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: 19212607
• MDR Text Key: 341593758
• Report Number: 3008766073-2024-00079
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2020
• Device Catalogue Number: LXMC16
• Device Lot Number: 12721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/03/2024; 05/11/2024
• Supplement Dates FDA Received: 05/09/2024; 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female