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

Model Number LXMC16

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/18/2021

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 was requested, and the following was obtained: what is the name of the hospital facility? (b)(6).Were there any intra-operative complications during implant? no complication during implant.Was there any hiatal or crural repair done at the same time as the implant? during implant there was a 3cm hiatal hernia.Site was queried to confirm the hiatal hernia noted in the device implant form was indeed repaired during the linx implant procedure.What is the current status of the patient? n/a if known, why did the patient discontinue in the study? n/a in the information it states: ¿diagnostic imaging = yes¿.Could we please receive a copy of the image? no.Mesh was not used.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

New log line 1 event details: start date: (b)(6) 2021.Alert date: (b)(6) 2021.Country of event: us.Model: lxmc16.Device lot number: 26974.Date of surgery: (b)(6) 2021.Adverse event term: food impaction: patient details: patient identifier: trx_2018_01: 01290-003.Sex: male.Age (at time of consent): (b)(6) years.Additional event details: site awareness date: (b)(6) 2021.End date: (b)(6) 2021.Severity: moderate.Is the adverse event serious? yes.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: yes, admission date: (b)(6) 2021 discharge date: (b)(6) 2021 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: yes.Diagnostic imaging: yes.Drug therapy: no.Observation: no.Linx explant: no.Other surgical intervention: no.Other intervention/treatment: yes.If other specify: food bolus in lower esophagus outcome: recovered/resolved according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated: blank did this event result in the patient¿s discontinuation of the study? yes.

Manufacturer Narrative

(b)(4).Date sent: 8/26/2021.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.The dhr for lot 26974 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 2/5/2024 additional information received; food bolus in lower esophagus => egd to remove food that was impacted.

• 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, MN 55126 ; 6107428552
• MDR Report Key: 12273845
• MDR Text Key: 277505043
• Report Number: 3008766073-2021-00156
• 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
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2024
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Device Lot Number: 26974
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 08/26/2021; 01/25/2024
• Supplement Dates FDA Received: 08/26/2021; 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male