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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

Pc (b)(4).Date sent: 01/10/2020.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.The following information was requested, but unavailable: do you have the linx product code (model number), lot number and serial number (if applicable)? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? do you have an autoimmune disease? are you currently taking steroids / immunization drugs? when you have your appointment with your physician, please let us know what, if any, next steps will be taken to address the symptoms you are having.Please let us know when you have any diagnostic testing done to address the symptoms you are experiencing.

Event Description

It was reported a linx device was implanted on (b)(6) twenty nineteen.Since that time, he has had pain, bloating, gas, and trouble swallowing.The patient thinks that the device was placed to high up above the sphincter.Physician had prescribed carafate suspension and omeprazole to address the abdominal pain that he is experiencing.The patient has an appointment scheduled with is physician to discuss the removal of the device and he will call back with any new information.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN ; 6107428552
• MDR Report Key: 9575287
• MDR Text Key: 178959402
• Report Number: 3008766073-2020-00009
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1