MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Catalog Number LXMC16

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Dysphagia/ Odynophagia (1815); Inflammation (1932); No Code Available (3191)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/19/2019.Additional information was requested, and the following was obtained: on what date did the implant take place? (b)(6) 2017.On what date did the explant take place? (b)(6) 2019.What is the product code for the linx device that was removed? lxmc16.What is the lot number of the linx device? 11831.What was the sizing technique that was used? linx supplied measuring device.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.How severe was the dysphagia/odynophagia before intervention? none.Were there any intra-operative complications during implant? none.Was there any hiatal or crural repair done at the same time as the implant? yes.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? acid exposure in the patient¿s esophagus as verified by capsule ph.What was the reason for removal of the linx device? acidic reflux and dysphagia.Was the device found in the correct position/geometry at the time of removal? yes.Was ph testing performed prior to explant to confirm recurrent reflux? yes.After implant, was the device initially effective in controlling reflux? short term ¿ (b)(6) 2017 egd for patient reported reflux symptoms.Mild grade a esophagitis.Taking pepcid prn.Demeester score 23 ¿ with a normal being < 14.7.When did the recurrent reflux begin? (b)(6) 2017.

Event Description

It was reported that the patient had daily heartburn, positive demeester scores (48.6), regular regurgitation, la grade a esophagitis, the patient also had a revision to a fundoplication.The lxmc16 was removed.Next steps required will be a follow up on (b)(6) 2019.

Manufacturer Narrative

(b)(4).Date sent: 10/09/2019.Device analysis: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The dhr for lot 11831 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9087286
• MDR Text Key: 162642413
• Report Number: 3008766073-2019-00464
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2020
• Device Catalogue Number: LXMC16
• Device Lot Number: 11831
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/09/2019
• Patient Sequence Number: 1