MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 14 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM14

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was received: what was the implant date? (b)(6) 2019.What is the lot number for the linx device? 22651 (product code lxm14).Was ph testing performed prior to explant to confirm recurrent reflux? yes, within manometry, egd and barium swallow.After implant, was the device initially effective in controlling reflux? not completely.Reduced reflux episodes but still partially present.When did the recurrent reflux begin? from the third month serious symptoms reappearance, condition gradually worsening till the explant.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that linx explant due to non-resolution of reflux symptoms one year after implantation.

Manufacturer Narrative

(b)(4).Date sent: 02/02/2021.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 22651 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: LINX 1.5T 14 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11003119
• MDR Text Key: 221270611
• Report Number: 3008766073-2020-00198
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Catalogue Number: LXM14
• Device Lot Number: 22651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Date Manufacturer Received: 01/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR