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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abdominal Pain (1685)

Event Date 07/26/2018

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced pain leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation and paraoesophageal hernia repair occurred on (b)(6) 2018.Patient began experiencing severe and extended coughing fit the evening of the implantation at home.The patient presented in the er the next morning and was determined to have a recurrent paraoesophageal hernia with a significant portion of the stomach herniated into the chest.The linx device was in proper anatomical position and appeared to be fine however the patient requested the device to be removed.The hernia was repaired during linx explant.The dr stated he did not think the recurrence (of the hernia) had anything to do with the linx device.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced pain leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation and paraoesophageal hernia repair occurred on (b)(6) 2018 at (b)(6) hospital.Patient began experiencing severe and extended coughing fit the evening of the implantation at home.The patient presented in the er at (b)(6) center the next morning and was determined to have a recurrent paraoesophageal hernia with a significant portion of the stomach herniated into the chest.The linx device was in proper anatomical position and appeared to be fine however the patient requested the device to be removed.The hernia was repaired during linx explant.The physician stated he did not think the recurrence (of the hernia) had anything to do with the linx device.The patient is doing well since device removal.

Manufacturer Narrative

Updated event to include implant and explant centers and patient status after device removal.Corrected initial reporter name and address to include the correct hospital.Updated report date.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 7854726
• MDR Text Key: 119493348
• Report Number: 3008766073-2018-00144
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

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: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 50 YR