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

Catalog Number	LXC14
Health Effect - Clinical Codes	Pain (1994); Ulcer (2274); Abdominal Distention (2601); No Code Available (3191)
Date of Event	09/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.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.Were the symptoms that were reported experienced prior to the linx being implanted? did the patient have ulcerative disease and/or the gastritis pre-implant? initially, did the linx effectively control the reflux? did the reported symptoms get worse over time?.
Event or Problem Description
It was reported that a linx explant procedure was done on (b)(6) 2018 (lxc14, serial # (b)(4), lot #5931).History: linx device implant date was on (b)(6) 2014.Back on (b)(6) 2018 the egd shows linx is in good position.Gastritis was severe (la grade d, pyloric and duodenal ulcers noted).Patient started on carafate and omeprazole.On (b)(6) 2018 the patient was experiencing heartburn, upper gastric pain and severe bloating and feels his linx device is not working for him.On (b)(6) 2018 patient was seen at office to discuss options.On (b)(6) 2018 explant undertaken based mostly on his peptic ulcer disease.Patient was converted to a lap toupe nissen.
Additional Manufacturer Narrative
(b)(4).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 5931 was reviewed.No ncs, reworks, or defects related to the complaint 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: 7985117
• Report Number: 3008766073-2018-00191
• Device Sequence Number: 148399
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2018
• Device Catalogue Number: LXC14
• Device Lot Number: 5931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/07/2018
• Patient Sequence Number: 1