MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number LXMC14

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); No Code Available (3191)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: do you have the linx product code? lxmc14.Lot number and serial number (if applicable)? 15286.What was the reason for removal of the linx device (e.G.No issue - patient requested removal, ongoing dysphagia, ongoing gerd symptoms, etc.)? persistent abdominal pain and diarrhea.If dysphagia, how severe was the dysphagia/odynophagia before intervention (mild, moderate or severe)? na.Did the dysphagia improve after the device was implanted initially? na.Did the patient have an autoimmune disease? patient presented pre-implant with chronic fatigue syndrome, fibromyalgia, endometriosis, chest pain, mild dysphagia and cough is the patient currently taking steroids / immunization drugs? no.When was the linx device implanted? (b)(6) 2017.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Was the device found in the correct position/geometry at the time of removal? yes.

Event Description

It was reported that the linx was removed.Egd was done.There were no patient consequences.

Manufacturer Narrative

(b)(4).The dhr for lot 15286 was reviewed.No ncs, defects, or reworks related to the product complaint were found.As the device was not returned, an analysis investigation could not be performed.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8438226
• MDR Text Key: 139417771
• Report Number: 3008766073-2019-00296
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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 Catalogue Number: LXMC14
• Device Lot Number: 15286
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/21/2019
• Patient Sequence Number: 1
• Patient Age: 51 YR