MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number LXMC14

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); High Blood Pressure/ Hypertension (1908); Pain (1994); Hernia (2240); Speech Disorder (4415)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent: 1/2/2024 maude report: mw5147926.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.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 11448 number, and no non-conformances related to the malfunction were identified.Lot 11448 was an affected lot of the 2018 linx recall.Additional information attached: patient was hypertensive and taken to urgent care for observation and later released after getting back to baseline.The surgeon's office that the implemented the device was contacted immediately to coordinate urgent follow - up.The concerned was that the linx device had migrated when the patient was moved into the mri machine.The patient was seen and expressed no new symptoms and that the pain was felt during the mri was resolved.Out of precaution, an esophagram was still ordered to verify device placement.The esophagram was completed on (b) (6) 2023 and reveled a new gap between 2 components of the device, suspected of device failure high blood pressure/hypertension additional information was requested, and the following was obtained: please clarify what is meant by ¿large gap¿? is the device broken? is the wire broken? is the device discontinuous? are there any photos of the device that you could send to product complaint1@its.Jnj.Com answer: thank you for reaching out about this complaint.Regarding your questions, i¿m afraid i may only be of limited help.What i mentioned in the report was based off of the esophagram that this patient completed on (b)(6) 2023: ¿linx device appears unchanged in position from 2018, though there is a larger gap between 2 of the components and overall circumference appears increased.¿ from the report¿s impressions: ¿linx device is unchanged in position, but there now a larger gap between 2 of the metallic components and increased circumference of the ring, suspected device failure.¿ the images were not obtained within corewell health, but i have requested the images from the study to be sent over to us for our radiologists to review in hopes to provide better clarity for you.The patient completed an mri cervical spine study on (b)(6) 2023.It was performed on a siemens 1.5t machine.The patient expressed acute abdominal pain to the mri technologist, was hypertensive after the mri, and required temporary admission to a local urgent care for observation until symptoms resolved.Patient identification is available upon request if necessary.Was this a 1.5 t device? yes it was.It was confirmed with the patient¿s blue implant card that she brought to her mri appointment what part of the body was being imaged? it was an mri cervical spine what was the field strength of the mri? 1.5 tesla (siemens aera fit 1.5t) 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 with a linx device had an mri on (b)(6) 2023 and the patient complained of pain during mri.After the mri the patient had an esophogram which showed that two of the beads have a larger gap between them and the circumference of the ring has increased with suspicions of device failure.The patient's dr.Has extended the offer to the patient to remove the device and will return to ethicon if explanted.

Manufacturer Narrative

(b)(4).Date sent: 1/9/2024 photo analysis: an x-ray image of the device in vivo was reviewed by a medical safety officer.As per medical safety officer: "the barium esophagram demonstrates a discontinuous linx device, located below the diaphragm." the mechanism/cause of failure is unknown as a hands-on analysis of the device is necessary to determine the cause of failure.No further investigation can be completed at this point.

Manufacturer Narrative

(b)(4) date sent: 6/13/2024.Additional information received: the patient reached out complaining of increased reflux symptoms and a new 1cm hiatal hernia.The surgeon is recommending a nissen fundoplication and removal of the broken linx reflux device.The patient¿s symptoms now also include voice hoarseness due to increased acid reflux that has significant impact on her occupational duties as a telephone representative for her company.

• Brand Name: 1.5T LINX, 14B
• 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: 18426011
• MDR Text Key: 331864723
• Report Number: 3008766073-2024-00003
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2024

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: 06/27/2020
• Device Catalogue Number: LXMC14
• Device Lot Number: 11448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/09/2024; 06/03/2024
• Supplement Dates FDA Received: 01/09/2024; 06/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention