MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC16

Device Problem Patient Device Interaction Problem (4001)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2020.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.The dhr for lot 16292 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: patient has no auto immune.Patient was put on steroids 10mg for two days and on tapering dosage.No abnormalities when removing device.Device was totally intact.On what exact date did the explant take place? (b)(6) 2020.What was the reason for removal of the linx device? dysphagia.Was there any hiatal or crural repair done at the same time as the implant? hiatal hernia repair.

Event Description

It was reported that an lxmc16 was ex-planted on (b)(6) 2020 due to dysphagia.

Manufacturer Narrative

(b)(4).Date sent: 08/14/2020.Additional information received: product code is a lxmc17.

Manufacturer Narrative

(b)(4).Date sent: 08/25/2020.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 lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10381899
• MDR Text Key: 202996556
• Report Number: 3008766073-2020-00114
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2020

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: 09/11/2021
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC17
• Device Lot Number: 16292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/07/2020; 08/14/2020
• Supplement Dates FDA Received: 08/14/2020; 08/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention