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

Model Number LXMC15

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

Patient Problems Diarrhea (1811); Dysphagia/ Odynophagia (1815); Vomiting (2144)

Event Date 12/27/2021

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: trx-2018-01: (b)(4).Panhandle surgical group: model: lxmc15, device lot number: 27935, adverse event term: vomiting, severity: mild, sex: female, age (at time of consent): (b)(6).Other intervention/treatment: yes if other specify: avoid all breads, eat every couple hours.Drug therapy: yes drug therapy (prescription) : no, yes.Outcome: recovered/resolved.Adverse event term: diarrhea, intervention/treatment: none: yes.Relationship to study device: possible relationship to primary study procedure adverse event term: dysphagia.Severity: mild, drug therapy: yes.Other intervention/treatment: yes.If other specify: avoid all breads, eat every couple hours.Adverse event term : week of (b)(6) 2021-(b)(6) 2022, dysphagia.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 via clinical trial patient trx-2018-01: (b)(4), dysphagia.Relationship to study device: possible.

Manufacturer Narrative

(b)(4).Dates sent: /28/2022.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 27935, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 4/18/2024.Additional information received: start date: 01 may 2023.Alert date: 11- apr- 2024.Country of event: us.Model: lxmc15.Device lot number: 27935.Date of surgery: (b)(6) 2021.Adverse event term: dysphagia.Patient details: patient identifier: (b)(6).Sex: female.Age (at time of consent): 52 years.Additional event details: site awareness date: 10 apr 2024.End date: 26 mar 2024.Severity: moderate.Is the adverse event serious? no.Death: no.Date of death: blank.Life-threatening illness or injury: no.Permanent impairment of a body structure or a body function: no required in-patient hospitalization or prolongation of existing hospitalization: no admission date: (b)(6) 2024 discharge date: (b)(6) 2024 resulted in medical or surgical intervention: no led to fetal distress, fetal death or a congenital abnormality or birth defect: no relationship to study device: possible relationship to primary study procedure: not related if related to the procedure, indicate which procedure the event is related to: blank intervention/treatment: none: no.Dilation performed: no.Indicate type of dilation? blank.Date of dilation: blank.Diagnostic intervention: no.Diagnostic imaging: no.Drug therapy: no.Observation: no.Linx explant: yes.Other surgical intervention: no.Other intervention/treatment: no.If other specify: blank.Outcome: recovered/resolved.According to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated: n/a did this event result in the patient¿s discontinuation of the study? yes.Updated log line 8:.Start date : (b)(6) 2023.Admission date : (b)(6) 2024: blank.Discharge date : (b)(6) 2024: blank.Event details: alert date: 11- apr- 2024.Date of explant: (b)(6) 2024.Country of event: us.Model: lxmc15.Device lot number: 27935.Date of implant: (b)(6) 2021.Patient details: patient identifier: (b)(6).Sex: female.Age (at time of consent): 52 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: #008 01may2023-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: yes.Endoscopic: no.Other: no.If other, specify: blank.Were any concomitant procedures performed?: no describe any notable observations during the explant procedure: none.

• Brand Name: 1.5T LINX, 15B
• 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: 13314620
• MDR Text Key: 286864554
• Report Number: 3008766073-2022-00021
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 27935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 02/28/2022; 04/11/2024
• Supplement Dates FDA Received: 02/28/2022; 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female