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 Chest Pain (1776); No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2017

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient requested the removal of a linx device as they "did not like the feeling of the linx device inside of them".The linx device was used as part of the anti-reflux procedure.-uneventful anti-reflux procedure with hiatal hernia repair and device implant on (b)(6) 2017.-uneventful linx device explant due to the patient's request on (b)(6) 2017; the patient was experiencing some chest pain and mild dysphagia at the time of removal.-device was found in the correct position/geometry at the time of explant.

Manufacturer Narrative

(b)(4).

Event Description

Following a laparoscopic anti-reflux procedure, a patient requested the removal of a linx device as they "did not like the feeling of the linx device inside of them" and they were experiencing esophageal spasms.The linx device was used as part of the anti-reflux procedure.Uneventful anti-reflux procedure with hiatal hernia repair and device implant on (b)(6) 2017.The patient "struggled with compliance of post-operative recommendations" and had 5 coaching sessions after anti-reflux procedure.Patient was taking valium, lyrica, and flexeril prior to removal which "did nothing".Esophagogastroduodenoscopy (egd) with dilation performed on (b)(6) 2017 with food bolus impaction.Uneventful linx device explant due to the patient's request on (b)(6) 2017; the patient was experiencing some esophageal spasms, chest pain, and mild dysphagia at the time of removal.Device was found in the correct position/geometry at the time of explant.The patient was doing "a little better" after removal; his esophageal/chest spasms are "not new" and he had a similar experience prior to device implant.

• 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: 6826529
• MDR Text Key: 83851758
• Report Number: 3008766073-2017-00098
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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: 09/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/21/2021
• Device Model Number: LXMC14
• Device Lot Number: 14622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• 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: 68 YR
• Patient Weight: 59