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

Catalog Number LXMC14

Device Problem Use of Device Problem (1670)

Patient Problems Bowel Perforation (2668); No Code Available (3191)

Event Date 02/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.Were there any difficulties noted with the linx device during implant? what does the surgeon believe to be the etiology of the gastric perforation? is there an alleged deficiency of the linx device suspected? if yes, please explain.How was the gastric perforation diagnosed? how was the gastric perforation treated in the re-operation? is the linx device still implanted? if no, is the linx available for return.

Event Description

It was reported that after the procedure held on (b)(6) 2018, there was a small gastric perforation, reoperation post op day two.(size 14 linx; linx model# lxmc14, lot# 17506).Small gastric perforation, reoperation post op day 2.No further information provided.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: the device is still in the patient.It was not removed.The device history record for lot 17506 was reviewed.No ncrs, defects, reworks, or protocols related to the device complaint were found.

Manufacturer Narrative

(b)(4).Corrected data: based on the additional information received there was no alleged deficiency of the device and no indication that the placement of the linx device caused or contributed to the event.This file is being considered not reportable.

• 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: 7957074
• MDR Text Key: 123490891
• Report Number: 3008766073-2018-00175
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2018

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: LXMC14
• Device Lot Number: 17506
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 10/23/2018; 10/23/2018
• Supplement Dates FDA Received: 11/12/2018; 11/14/2018
• Patient Sequence Number: 1