MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Nonstandard Device (1420); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4), unknown.As a lot was not provided, a device history could not be performed.

Event Description

It was reported that in (b)(6) 2015, he had an unknown linx implantation, due to test results for acid reflux.The patient experienced heartburn a year post op.The patient took tums to resolve the heartburn.After receiving a recall letter at the beginning of 2018 for the linx device that was implanted, the patient returned to the hospital and consulted with a different doctor, that indicated the implanted linx device was stuck in the open position and scar tissue had grown around the device.No explant procedure has been scheduled.The doctor prescribed omeprozol for thirty days.The patient is continuing to experience heart burn.

Manufacturer Narrative

(b)(4).Additional information received: spoke with patient who advised that he underwent imaging and the surgeon advised the linx device ¿is not broken.¿ he was advised that he has some scar tissue that is preventing the device from providing full relief from the gerds symptoms.Patient indicated that he¿s not concerned about this and there are no plans to explant.He does not know what size was implanted.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8277733
• MDR Text Key: 134097260
• Report Number: 3008766073-2019-00264
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

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: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 01/30/2019
• Patient Sequence Number: 1