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

Catalog Number LXMC15

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 is the product code for the linx device that was explanted? was this the clasp linx or the suture linx? did the patient have an autoimmune disease? is the patient currently taking steroids/immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? did the dysphagia improve after the device was implanted initially? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal? current patient status?.

Event Description

It was reported that the patient was experiencing chronic esophageal spasms and had a linx explant on (b)(6) 2018.The entire device was removed from the patient.There was nothing wrong with the device.It isn't known if the device will be replaced.It isn't known the status of the patient.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: what is the product code for the linx device that was explanted? device lot 12446 was this the clasp linx or the suture linx? clasp did the patient have an autoimmune disease? no is the patient currently taking steroids / immunization drugs? no did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no how severe was the dysphagia/odynophagia before intervention? n/a.Did the dysphagia improve after the device was implanted initially? n/a.Were there any intra-operative complications during implant? no was there any hiatal or crural repair done at the same time as the implant? no what was the reason for removal of the linx device? esophageal spasm, chest pain was the device found in the correct position/geometry at the time of removal? yes based on the lot number reported, 12446, it was determined that the product code is lxmc15.

Manufacturer Narrative

(b)(4).The dhr for lot 12446 was reviewed.No ncs, reworks, or defects related to the product complaint were found.

• 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: 8141686
• MDR Text Key: 129600492
• Report Number: 3008766073-2018-00218
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

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: 10/12/2020
• Device Catalogue Number: LXMC15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 12/11/2018; 01/30/2019
• Supplement Dates FDA Received: 01/04/2019; 01/30/2019
• Patient Sequence Number: 1