MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC17; ANTI-REFLUX IMPLANT

Catalog Number	LXC17
Health Effect - Clinical Codes	Heartburn/Indigestion (1883); No Code Available (3191)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 11/12/2019.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 7765 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Lot 7765 was an affected lot of the 2018 linx recall.If further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was ph testing performed prior to explant to confirm recurrent reflux? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin?.
Event or Problem Description
It was reported by the sales rep that post implant to a linx device the patient's gerd symptoms returned.The device was explanted on (b)(6) 2019, and the patient was converted to a nissen.
Additional Manufacturer Narrative
(b)(4).Date sent: 01/02/2020.Additional information requested and received: implant date is (b)(6) 2018.The device initially was effective in controlling reflux.

• Brand Name: LXC17
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9310174
• Report Number: 3008766073-2019-00541
• Device Sequence Number: 10879738
• Product Code: LEI
• UDI-Device Identifier: 00855106005189
• UDI-Public: 00855106005189
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 03/11/2019
• Device Catalogue Number: LXC17
• Device Lot Number: 7765
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/02/2020
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 108