MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number LXMC14

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 01/17/2020.Additional information received: date started: (b)(6) 2019.Date of site awareness: (b)(6) 2019.Status: ongoing.Intensity: moderate.Anticipated: yes.Treatment: medication, amitriptyline 10 mg daily.Questions: will the device be explanted? no plans to explant.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes, hiatal hernia repair.Had the patient had any diagnostic testing done to address the symptoms they experienced while the device was implanted? no testing done.Did they have an autoimmune disease? emr shows a history of psoriasis but current notes do not indicate that this is active.Recent pes state skin is normal, without rashes or lesions.Has the patient been prescribed medication? if yes, why was the medication prescribed? was the medication prescribed to treat the dysphagia, gerd, etc.Were they taking this medication prior to implant? (b)(6) 2019 (at hospital discharge post-implant) ondansetron 4-8mg q 8hrs prn.(b)(6) 2019 amitriptyline 10mg qd at bedtime.Prescribed for esophageal spasm.Not currently taking nexium as was prior to implant.Are they currently taking steroids / immunization drugs? no.

Event Description

It was reported that the patient experienced, dysphagia.Subject with long time severe reflux, heartburn and dysphagia pre-op.At 3-week post-op visit c/o pain and heartburn when swallowing solids.Also complains of nausea.

• Brand Name: 1.5T LINX, 14B
• 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: 9601103
• MDR Text Key: 181958159
• Report Number: 3008766073-2020-00014
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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: 01/14/2020

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: 11/29/2022
• Device Catalogue Number: LXMC14
• Device Lot Number: 24157
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female