MAUDE Adverse Event Report: TORAX MEDICAL, INC. LX13; ANTI-REFLUX IMPLANT

Catalog Number LX13

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994); No Code Available (3191)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dhr for lot 4160 was reviewed.No ncs, reworks, or defects related to the product complaint were found.Additional information requested and received: clarification is needed.It was reported that 2 beads migrated into the esophagus.Were there 2 beads that ¿eroded¿ into the esophagus as migration is when the entire device moves out of place? was the clasp closed? the device was placed on the right place.2 beats were migrated into the oesophagus.The clasp was closed.Patient wanted to keep device.Device not available to return.

Event Description

Thoracic surgery.Linx ring had been implanted (b)(6) 2014.Now patient had complained about having pain.Linx ring was found to have migrated.2 beets were migrated into the ösophagus.Ring was explanted laparoscopically on (b)(6) 2019.Surgeon used sleeve and overstitched.Patient left hospital after 5 days and is reported to be fine.

Manufacturer Narrative

(b)(4).Endoscopic images were received showing eroded beads visible in the lumen of the esophagus.

• Brand Name: LX13
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8408235
• MDR Text Key: 138395413
• Report Number: 3008766073-2019-00284
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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 Expiration Date: 11/20/2016
• Device Catalogue Number: LX13
• Device Lot Number: 4160
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 04/11/2019
• Patient Sequence Number: 1