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

Catalog Number LXMC14

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that the linx device was removed.The linx was removed it on the 15th, the patient had the device for about three months.The patient had initially lost ten or fifteen lbs after the procedure was done, but the reflux and the heartburn was gone, there was no device malfunction, the esophagus started to dilate out and expand above the linx device, the surgeon attempted to do a endoscopic dilation (unknown exactly when the patient was dilated but it was potentially between month two and three) and put the patient on steroids and nothing seemed to elevate the symptoms so the device was removed.There were no noticeably product issues, and it was discarded, our hypothesis is that the patient did not adhere to the post implant diet, so that when the device healed it healed in the closed position.The hiatal hernia looked great.The device was implanted around three months ago, believes it was oct/nov, does not know for sure.There was a little bit of dysphagia.The device was explanted because there was concern for the esophagus dilation (it was expanding and dilating out) above the linx device.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 8376041
• MDR Text Key: 137362532
• Report Number: 3008766073-2019-00282
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2019
• Initial Date FDA Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1