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

Model Number LXMC14

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

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Vomiting (2144); Obstruction/Occlusion (2422)

Event Date 08/15/2021

Event Type  Injury  

Event Description

It was reported via clinical trial patient (b)(6) experience, vomiting.The event was not related to the study device.

Manufacturer Narrative

(b)(4).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 received: model: lxmc-14.Device lot number: 26971.Date of surgery: (b)(6) 2021 adverse event term: vomiting.Drug therapy: yes.Adverse event term: vomiting, constipation, abdominal pain.Required in-patient hospitalization or prolongation of existing hospitalization : no => yes severity : moderate severe.Awareness date : (b)(6) 2021.Admission date: blank (b)(6) 2021.Is the adverse event serious? (if yes, check all that apply) : no => yes.Relationship to study device : blank probable.Relationship to study procedure : blank probable.Adverse event : dysphagia.Additional information was requested, and the following was obtained: did the subject require additional medical treatment for issues with linx device? if yes, describe the medical treatment provided: hospitalization.If medications were part of the medical treatment, were the medications prescription or over the counter? prescribed.

Manufacturer Narrative

(b)(4).Date sent: 10/7/2021.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.The dhr for lot 26971 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 10/28/2022.Additional information received: relationship to study device: unlikely.Dilation performed: yes.Indicate type of dilation? mechanical.Date of dilation: (b)(6) 2022.If event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : blank no.Intervention/treatment: (check 'none' or all that apply)none : yes => no.If event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : no => n/a.

Manufacturer Narrative

(b)(4).Date sent: 8/16/2023.Additional information received: awareness date : 19 apr 2022/ 6 sep 2022.

• 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: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 12421482
• MDR Text Key: 280529998
• Report Number: 3008766073-2021-00179
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2023

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: 04/30/2024
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 26971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 10/07/2021; 10/27/2022; 08/10/2023
• Supplement Dates FDA Received: 10/07/2021; 10/29/2022; 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female