MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Catalog Number LXMC17

Device Problem Protective Measures Problem (3015)

Patient Problem No Code Available (3191)

Event Date 11/12/2018

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 were the indications for surgery? how long was the linx implanted? was there an alleged deficiency with the linx device? if yes, please explain.Why did the surgeon feel that there was a higher chance of erosion following the gastrectomy?.

Event Description

It was reported that during a gastrectomy, the size 17 linx was compressing the esophagus and the doctor was worried there would be erosion and severe dysphagia, if left implanted.The doctor removed the device and performed a laparoscopic toupet fundoplication procedure to complete the procedure.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 01/17/2019.The dhr for lot 21922 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8111362
• MDR Text Key: 128630936
• Report Number: 3008766073-2018-00212
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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: 11/12/2018

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 Catalogue Number: LXMC17
• Device Lot Number: 21922
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/17/2019
• Patient Sequence Number: 1