MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number LXMC15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Nausea (1970); Vomiting (2144); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2018.The dhr for lot 8576 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Event Description

It was reported that the linx was placed on (b)(6) 2018.Pt reported sxs of dysphagia on (b)(6) 2018.Linx was placed on (b)(6) 2018.Pt reported sxs of dysphagia on (b)(6) 2018.Symptom of nausea & vomiting for four to five days.Barium swallow was ordered.Pt became inpatient (b)(6) 2018.P she was given iv hydration and prednisone.Discharged on (b)(6) 2018.Pt was seen in office on (b)(6) 2018 with improvement stating she felt better.Patient is 4 weeks post explant.She reported that she no longer had dysphagia.She is eating well and reported.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN ; 6107428552
• MDR Report Key: 9400966
• MDR Text Key: 168827888
• Report Number: 3008766073-2019-00552
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2019
• Device Catalogue Number: LXMC15
• Device Lot Number: 8576
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1