MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM

Model Number LS12

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dysphagia/ Odynophagia (1815); Vomiting (2144); Foreign Body In Patient (2687)

Event Date 08/13/2014

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia.The dysphagia occurred after an episode of retching/vomiting when prepping for a colonoscopy.Two beads of the linx device were subsequently found to be visible in the esophagus.Anti-reflux procedure and linx device implantation occurred on (b)(6) 2012.Acute onset of severe dysphagia on (b)(6) 2014 following retching/vomiting episode.Diagnostic endoscopy on (b)(6) 2014 revealed two beads (titanium encased magnets) to be visible in the esophagus.The linx device was found intact.Endoscopic removal of five beads and laparoscopic removal of seven beads (entire linx device) occurred on (b)(6) 2014.Patient underwent toupet fundoplication on (b)(6) 2014.The patient is recovering without complication.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Manufacturer (Section D): TORAX MEDICAL, INC.; shoreview MN
• Manufacturer Contact: 4188 lexington ave n; shoreview, MN 55126 ; 6513618907
• MDR Report Key: 4118098
• MDR Text Key: 4922327
• Report Number: 3008766073-2014-00023
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2014

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 Expiration Date: 04/10/2012
• Device Model Number: LS12
• Device Lot Number: 3457
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2014
• Initial Date FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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: 50 YR
• Patient Weight: 74