MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC16; ANTI-REFLUX IMPLANT

Catalog Number	LXC16
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Nausea (1970); Pain (1994); Vomiting (2144); Abdominal Distention (2601); No Code Available (3191)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: unknown, assumed the 1st day of month that complaint was reported.Additional information received: 75 inches, (b)(6) lbs, 27.5 bmi.There was a hiatal hernia repair completed at time of implant.First implant done on (b)(6) 2015.Bravo capsule test on (b)(6) 2015: heartburn, chest pain, regurgitation, pain, belching, bloating, gas, diarrhea.Patient has had persistent reflux since his initial linx surgery; symptoms had improved, remained on ppis.Had an endoscopy as part of pas follow up and was found to have an enlarged hiatal hernia.Surgeon discussed repair of the hernia, the patient wanted to proceed.(b)(6).
Event or Problem Description
Patient had replacement of his linx today.This was a minimal dissection procedure initially and developed in to a peh.Today the peh was repaired.Dr.Wanted it noted that the only reason to replace the linx was because he had a 1.5t device.Linx device explanted and replaced with new linx device.
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 6275 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: LXC16
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9072319
• Report Number: 3008766073-2019-00453
• Device Sequence Number: 16581782
• Product Code: LEI
• UDI-Device Identifier: 00855106005172
• UDI-Public: 00855106005172
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 06/05/2018
• Device Catalogue Number: LXC16
• Device Lot Number: 6275
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 100