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

Model Number LXMC16

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 06/17/2021

Event Type  Injury  

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: lxmc16 device lot number: 26705 date of surgery: (b)(6) 2021.Patient identifier: (b)(6).Institute of esophageal and reflux surgery sex: female age (at time of consent): (b)(6).Adverse event term: dysphagia.Site awareness date: (b)(6) 2021.Severity: moderate.Relationship to study device: unlikely relationship to primary study procedure: possible if related to the procedure, indicate which procedure the event is related to: index intervention/treatment: dilation performed: yes.Indicate type of dilation? mechanical.Date of dilation: (b)(6) 2021.

Event Description

It was reported via clinical trial patient experienced dysphagia.The event was not related to the study device.

Manufacturer Narrative

(b)(4).Date sent: 1/27/2022.Investigation summary: 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.A manufacturing record evaluation was performed for the finished device batch number 26705, and no non-conformances were identified.

Manufacturer Narrative

(b)(4); date sent: 12/2/2022.Additional information received: relationship to study device: unlikely, relationship to primary study procedure: possible, dilation performed: yes, indicate type of dilation? mechanical, date of dilation: (b)(6) 2021, date of dilation : (b)(6) 2021, start date : (b)(6) 2022 - (b)(6) 2021.Relationship to study device: unlikely, relationship to primary study procedure: possible, dilation performed: yes, indicate type of dilation? mechanical, date of dilation: (b)(6) 2021, linx explant: yes, linx explant : no -yes, start date : (b)(6) 2021 - (b)(6) 2022.

Manufacturer Narrative

(b)(4).Date sent: 1/30/2024.Additional information received: date of dilation : 24 oct 2021 => 24 oct 2022.Updated log line 1: awareness date : 07 dec 2022 => 01 dec 2022.Updated log line 1: awareness date : 17 jun 2021 => 07 dec 2022.

Manufacturer Narrative

(b)(4) date sent: 3/26/2024 additional information received: start date : on (b)(6) 2021 and on (b)(6) 2022.Log line 1 updated date of dilation : on (b)(6) 2022 ,and on (b)(6) 2021, awareness date : 01 dec 2022 , 17 jun 2021, start date : on (b)(6) 2022 and on (b)(6) 2021.Outcome : not recovered/not resolved recovered/resolved alert date: on (b)(6) 2024, date of explant: on (b)(6) 2022, country of event: ous, model: lxmc16, device lot number: 26705, date of implant: on (b)(6) 2021.Patient details patient identifier: (b)(6), sex: female, age (at time of consent): 55 years.Additional event details was the linx explant a result of an adverse event per protocol definitions?: yes if yes, choose the primary ae log line, start date and term: #001 (b)(6) 2021-dysphagia if no, what was the reason for the explant? (check all that apply) participant had anxiety about implant: no medical need for high field strength mri or other testing: no participant wishes to have alternative gerd treatment requiring linx explant: no continued gerd symptom: no did not meet participant expectations: no other: no if other, specify: blank describe the technique used for explant (check all that apply) laparoscopic: no endoscopic: no other: yes if other, specify: unknown were any concomitant procedures performed?: no describe any notable observations during the explant procedure: unknown updated explant notification: date of linx explant : on (b)(6) 2022, end date : blank on (b)(6) 2022.Updated log line 1: start date : on (b)(6) 2021.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13003776
• MDR Text Key: 282769281
• Report Number: 3008766073-2021-00261
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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,Followup
• Report Date: 03/26/2024

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: 02/25/2024
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Device Lot Number: 26705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 01/27/2022; 12/01/2022; 01/20/2024; 03/11/2024
• Supplement Dates FDA Received: 01/27/2022; 12/02/2022; 01/30/2024; 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female