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

Catalog Number LXMC15

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Pyrosis/Heartburn (1883); Swelling (2091); Abdominal Distention (2601); No Code Available (3191)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 03/23/2020.Abdominal distention device implanted.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What are the next steps /management plan?.

Event Description

It was reported that the patient had an unknown linx device implanted on (b)(6) 2017, due to acid reflux.The patient initially had relief from gerd after implant but more recently has experienced bloating of his stomach and lots of phlegm with a cough.Then the patient continued to have acid reflux as well as coughing up phlegm, swollen, distended and tender stomach.The patient returned to his implant doctor to have the linx expanded and the doctor chose not to expand, indicating it looked fine.The patient continued to have the issues mentioned, returned to his implant doctor, had the linx was expanded but he continued to have the issues with acid reflux, phlegm, and swollen, distended and tender stomach.The patient returned to the implant doctor, requesting to have the device removed and the implant doctor wasn't responsive to the patient's request.No current plans have been made to have the linx explanted.

Manufacturer Narrative

(b)(4).Date sent: 04/13/2020.H10: corrected data = d4 (catalog).Additional information received: patient demographics: st (dob: (b)(6) 1954).Lot 8101 corresponds to product code: lmxc15.The dhr for lot 8101 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 06/12/2020.Additional information received: the plan is to remove the device but nothing has been scheduled to date.

Manufacturer Narrative

(b)(4).Date sent: 10/27/2020.Additional information was requested, and the following was obtained: the device was explanted on (b)(6) 2020 and was discarded.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 9864883
• MDR Text Key: 188064705
• Report Number: 3008766073-2020-00054
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/02/2020

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: 05/04/2019
• Device Catalogue Number: LXMC15
• Device Lot Number: 8101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 03/24/2020; 05/19/2020; 10/13/2020
• Supplement Dates FDA Received: 04/13/2020; 06/12/2020; 10/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR