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

Model Number LXMC14

Device Problems Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); No Code Available (3191)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 11/16/2020 the lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was received: what was the implant date? (b)(6) 2018 (don¿t know the exact date only month/year) what is the lot number for the linx device? unknown.Was ph testing performed prior to explant to confirm recurrent reflux? unknown.After implant, was the device initially effective in controlling reflux? unknown.When did the recurrent reflux begin? unknown.The device was taken out without my notification.I wasn¿t given much information.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 an explant was performed on (b)(6) 2020 due to the patient having reoccurring reflux.Prior to the linx implant the patient had a peri oral endoscopic myotomy.The linx implant was converted to a fundoplication.There is no additional information.

Manufacturer Narrative

(b)(4).Date sent: 12/01/2020.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.

Manufacturer Narrative

(b)(4).Date sent: 12/02/2020.H11: corrected data = h6 investigation conclusions: d12 (known inherent risk of device); d14 (no problem detected) were omitted on the previous report.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10842897
• MDR Text Key: 216327763
• Report Number: 3008766073-2020-00176
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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: 10/26/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 11/30/2020; 12/01/2020
• Supplement Dates FDA Received: 12/01/2020; 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1