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

Catalog Number LXMC15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/3/2024.B3: only event year known: 2023.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: the event description states ¿case completed with another device of the same product code.¿ did the patient receive another linx device? if yes, what size? was the device explanted on (b)(6) 2023? if not, why not? is there another explant date scheduled? prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? what is the product code for the linx device that was removed? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? was the device found in the correct position/geometry at the time of removal? is the device returning for analysis? if yes, to whom should the shipper kit be sent to? 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 there is an upcoming linx explant.Device to be removed per patient request.Persistence of nausea and vomiting with no findings as of why.Pt does not want foreign body in her belly any longer.Device is functioning fine, case completed with another device of the same product code.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 1/25/2024.Additional information received: implanted on (b)(6) 2020; explant on (b)(6) 2023; no new implant; lot number 25107; pt had full workup: la b esophagitis, small hiatal hernia on barium study, des on manometry otherwise normal, demeester 67.No dilations; pop plus 2; no autoimmune disease or other confounding data; no operative issues.Device to be removed per patient request.Persistence of nausea and vomiting with no findings as of why.Pt does not want foreign body in her belly any longer.Device is functioning fine.

Manufacturer Narrative

(b)(4) date sent: 2/5/2024 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 25107 number, and no non-conformances related to the malfunction were identified.

• 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 ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 18435467
• MDR Text Key: 331795191
• Report Number: 3008766073-2024-00007
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

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: 06/19/2023
• Device Catalogue Number: LXMC15
• Device Lot Number: 25107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/09/2024; 02/05/2024
• Supplement Dates FDA Received: 01/25/2024; 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2019
• 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
• Patient Outcome(s): Required Intervention