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

Catalog Number	LXC14
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional 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.The dhr of lot 6380 was reviewed.No ncs, reworks, or defects were found.
Event or Problem Description
It was reported that post-implant, since linx implant, patient has been not completely satisfied with the control of her lpr symptoms particularly throat clearing.Patient reports over the years it appeared to be worse despite taking pepcid leading the patient to decide to pursue explant at georgetown hospital.It is unknown if there were any adverse patient consequences.Additionally, ppi's and h2 blockers were prescribed.The patient was converted to a nissen after the linx explant.She is doing well and is off ppi/h2 blockers and is asymptomatic.

• Brand Name: LXC14
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8789219
• Report Number: 3008766073-2019-00386
• Device Sequence Number: 19492823
• Product Code: LEI
• UDI-Device Identifier: 00855106005158
• UDI-Public: 00855106005158
• Combination Product (Y/N): N
• Initial Reporter State: VA
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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: 06/25/2018
• Device Catalogue Number: LXC14
• Device Lot Number: 6340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/15/2019
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 75