MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC14; ANTI-REFLUX IMPLANT

Catalog Number	LXC14
Health Effect - Clinical Codes	Vomiting (2144); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Only event year is known: 2019 batch # unk 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 4525 was reviewed.No ncs, reworks, or defects were found.Additional information received: were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? no.Please specify the symptoms the patient was experiencing prior to implant (gerd reflux, dysphagia, pain during eating, at night, etc., )? gerd.Please specify the symptoms the patient was experiencing while the device was implanted (gerd reflux, dysphagia, pain during eating, at night, etc., )? patient reports primary issue is ineffectiveness of symptom relief as manifested by continued presence of refractory heartburn and regurgitation.Had the patient had any diagnostic testing done to address the symptoms they experienced while the device was implanted? if yes, what diagnostic testing was done, and have they received the test results? patient underwent esophageal ph testing in (b)(6) 2019.Did they have an autoimmune disease? no.Has the patient been prescribed medication? yes, ppis qd and prn antacids.Are they currently taking steroids / immunization drugs? no.
Event or Problem Description
It was reported that after a linx 14 clasp implant procedure, (lot# 4525 serial# (b)(4)) the patient reported continued presence of refractory heartburn and regurgitation.The patient wanted to move forward with explant.The physician explanted the linx and converted to a nissen fundoplication.They patient stayed overnight.Pas subject (b)(6).
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Date sent: 09/16/2019.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 4525 was reviewed.No ncs, reworks, or defects were found.

• Brand Name: LXC14
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8617128
• Report Number: 3008766073-2019-00350
• Device Sequence Number: 2169850
• Product Code: LEI
• UDI-Device Identifier: 00855106005158
• UDI-Public: 00855106005158
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2017
• Device Catalogue Number: LXC14
• Device Lot Number: 4524
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 05/28/2019; 08/20/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/17/2019; 09/16/2019
• Patient Sequence Number: 1