MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

Device Problems Device Appears to Trigger Rejection (1524); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pain (1994); Hernia (2240)

Event Date 06/22/2023

Event Type  Injury  

Event Description

It was reported that a 65 yo female patient with history of gerd, asthma, sleeve gastrectomy converted to rygb in 2013 for persistent lung disease attributed to reflux and sleep apnea.Patient had linx implanted to treat gerd and she did well initially but had to restart her proton pump inhibitor the following year.An egd in (b)(6) 2022 indicated mild reflux and a 2cm hiatal hernia.An xray in (b)(6) 2022 taken after patient fell and was experiencing lower back pain indicated her linx device was discontinuous.No information as to patient¿s current condition is reported at this time.

Manufacturer Narrative

(b)(4).Date sent: 7/7/2023.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.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.

Manufacturer Narrative

(b)(4).Date sent: 8/8/2023 investigation summary 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 lot number 14555, and no related nonconformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 8/30/2023.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 1/9/2024 photo analysis: x-ray images of the device in vivo were reviewed by a medical safety officer.As per medical safety officer: "the images reviewed demonstrate a linx device located below the diaphragm that is discontinuous." 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.A manufacturing record evaluation was performed for the finished device 14555 number, and no non-conformances related to the malfunction were identified.

• Brand Name: 1.5T LINX, 17 BEADS
• 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: 17277104
• MDR Text Key: 318557198
• Report Number: 3008766073-2023-00135
• Device Sequence Number: 1
• Product Code: LEI
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 14555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 76 KG