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

Model Number LXMC15

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The dhr for lot 23772 was reviewed.No ncs, defects, or reworks related to the product complaint were found if information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

The following was reported that the patient had ongoing diarrhea.Start date: (b)(6) 2020 (new onset 21 days after the linx implant).It may be related to irritation of the vagus nerve stimulating the gastrocolic reflex or it could be related to stopping high dose ppis, which this patient was on for 20 years.The patient is experiencing dysphagia after eating.The patient has not been eating as much due to the diarrhea.The diarrhea has improved so patient is eating more and experiencing intermittent dysphagia.Patient will start eating small amounts every two hours.Medrol dose pack started.There are no plans to explant the device.The patient is very pleased with her results.

Manufacturer Narrative

(b)(4).Date sent: 01/08/2021.Additional information received: presumed candidal esophagitis discovered during egd.Pt.Reported no symptoms.Pt.Was recently on a course of antibiotics which may be the cause.

Manufacturer Narrative

(b)(4), date sent: 3/22/2021.Additional information received: date of resolution: 29 dec 2020 resolution of candidal esophagitis.

Manufacturer Narrative

(b)(4), date sent: 2/11/2021.Additional information received: the patient was prescribed diflucan-200 mg.Po, qd, (b)(6) 2020 through (b)(6) 2020.Pathology confirmed candidal esophagitis.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10199986
• MDR Text Key: 197811429
• Report Number: 3008766073-2020-00093
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/11/2020

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 Expiration Date: 10/10/2022
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 23772
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 12/17/2020; 01/19/2021; 03/01/2021
• Supplement Dates FDA Received: 01/08/2021; 02/11/2021; 03/22/2021
• Patient Sequence Number: 1
• Patient Age: 40 YR