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

Model Number LXMC15

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 11/18/2021

Event Type  Injury  

Event Description

It was reported via clinical trial patient experienced dysphagia.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: (b)(6) hospital.Model: lxmc15.Device lot number: 28491.Date of surgery: (b)(6) 2021.Adverse event term: dysphagia.Causal relationship to primary study procedure: not related.Causal relationship, drug therapy (prescription) yes.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: 1/5/2022.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 lot number 28941, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 3/9/2022.Additional information received: outcome : not recovered/not resolved: recovered/resolved.

Manufacturer Narrative

(b)(4).Date sent: 2/1/2022.Additional information received: dilation performed: yes.Indicate type of dilation? pneumatic.Date of dilation: (b)(6) 2022.

Manufacturer Narrative

(b)(4).Date sent: 3/3/2022.Additional information provided: dilation performed: yes.Indicate type of dilation? pneumatic.Date of dilation: on (b)(6) 2022.Drug therapy: yes.Relationship to study device: causal relationship.Relationship to primary study procedure: not related.

Manufacturer Narrative

(b)(4).Date sent: 5/19/2022.Additional information received: not recovered/not resolved : recovered/resolved.

Manufacturer Narrative

(b)(4), date sent: 11/17/2022.Additional information received: other intervention/treatment: yes.If other specify: dilation scheduled.Relationship to study device: causal relationship.Relationship to study device: causal relationship.Relationship to primary study procedure: not related.Dilation performed: yes.Indicate type of dilation? pneumatic.Date of dilation: (b)(6) 2022.If other, specify : blank - dilation completed.Date of dilation : blank - (b)(6) 2022.Dilation performed : no - yes.Indicate type of dilation? : blank - pneumatic.If other, specify : dilation scheduled - blank.

Manufacturer Narrative

(b)(4); date sent: 11/21/2022.Additional information received: end date : blank 17 nov 2022.Outcome : not recovered/not resolved - recovered/resolved.

Manufacturer Narrative

(b)(4).Date sent: 10/30/2023.Additional information received: start date: on (b)(6) 2023, alert date: on (b)(6) 2023, country of event: us, model: lxmc15, device lot number: 28491, date of surgery: on (b)(6) 2021, adverse event term: dysphagia.Patient details: patient identifier: (b)(6), sex: male, age (at time of consent): 60 years.Additional event details: site awareness date: 16 oct 2023, end date: blank, severity: mild, 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: blank discharge date: blank 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: causal 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: no, other surgical intervention: no, other intervention/treatment: no, if other specify: blank, outcome: not recovered/not 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? no.Intervention/treatment: (check 'none' or all that apply) none : no / yes.

Manufacturer Narrative

(b)(4).Date sent: 1/11/2024.Additional information received: date of dilation : blank => (b)(6) 2023 dilation performed : no => yes.Indicate type of dilation? : blank => pneumatic.Drug therapy (prescription) : no => yes.Intervention/treatment (check 'none' or all that apply)none : yes => no.Outcome: not recovered/not resolved => recovered/resolved.

• 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: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13024644
• MDR Text Key: 285162534
• Report Number: 3008766073-2021-00262
• 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,Followup,Followup
• Report Date: 01/11/2024

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: 28491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 01/05/2022; 01/18/2022; 02/28/2022; 03/07/2022; 05/12/2022; 11/03/2022; 11/18/2022; 10/16/2023; 12/27/2023
• Supplement Dates FDA Received: 01/05/2022; 02/01/2022; 03/03/2022; 03/09/2022; 05/20/2022; 11/17/2022; 11/21/2022; 10/30/2023; 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male