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 Problems Eructate (1839); Vomiting (2144); No Code Available (3191)

Event Date 11/30/2016

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced belching, vomiting, and gastroparesis.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation reported as approximately (b)(6) 2016.After implant patient experienced belching which progressed to vomiting with no specific date for onset of symptoms given.A gastric emptying study was performed in response to the patient's symptoms which showed some gastroparesis; it is not clear whether a gastroparesis test was performed prior to device implant.Requests for additional information were made to the doctor several times to no avail at the time of this report.

Manufacturer Narrative

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced belching, vomiting, and gastroparesis / delayed gastric emptying.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implanted (b)(6) 2016.Physician confirmed that the posterior vagus was excluded and that the hepatic branch of the vagus was not cut during the implant procedure.After implant patient experienced belching which progressed to vomiting with no specific date for onset of symptoms given.A gastric emptying study was performed in response to the patient's symptoms which showed gastroparesis / delayed gastric emptying; no test for gastroparesis / delayed gastric emptying was performed prior to implant.Patient's gastroparesis / delayed gastric emptying is reported as improving.

• 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
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: daniel hoseck ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6309545
• MDR Text Key: 66763008
• Report Number: 3008766073-2017-00019
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

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: Physician
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 35 YR
• Patient Weight: 88