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

Model Number LXMC14

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

Patient Problems Dysphagia/ Odynophagia (1815); No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2017

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient requested the removal of a linx device; no clinical symptoms experienced.The linx device was used as part of the anti-reflux procedure.Patient was implanted with a 14 bead linx clasp device during an anti-reflux procedure on an unknown date.Uneventful linx device explant due to the patient's request on (b)(6) 2017.Device was found with a fibrosis capsule around the device.

Manufacturer Narrative

Update to include implant date and details, dysphagia symptoms experienced, device found in the correct position, and patient status after removal.Update to include pre-implant and pre-explant testing performed.Update to include patient bmi and history.Update to include device traceability.Update to include device implant date.Update to include device manufacture date.(b)(4).

Event Description

Following a laparoscopic anti-reflux procedure, a patient requested the removal of a linx device while experiencing some moderate dysphagia.The linx device was used as part of the anti-reflux procedure.Patient had an anti-reflux procedure including linx device implantation and hernia repair on (b)(6) 2016.Uneventful linx device explant due to the patient's request while experiencing some moderate dysphagia on (b)(6) 2017.Device was found in the correct position/geometry with a fibrosis capsule around the device.Patient was reported as doing well 2 weeks post-removal.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: jessica ahlborn ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6678943
• MDR Text Key: 78763348
• Report Number: 3008766073-2017-00069
• 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: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/22/2020
• Device Model Number: LXMC14
• Device Lot Number: 11954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2016
• 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; Other
• Patient Age: 39 YR