MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Model Number LXMC17

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Headache (1880); Pyrosis/Heartburn (1883); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 03/31/2020.Device remains implanted.Additional information was requested and the following was obtained: what is the internal medicine doctor¿s diagnosis of the current symptoms? response: (b)(6) 2020: clinic visit reflux had resolved.Plan to wean off ppi.3/26/20: sc spoke w/subject.Face tingling and pain stopped (b)(6) 2020.Esoph spasms 80% better after medrol pack complete, (b)(6) 2020.Unsuccessful weaning from ppi.Now on 20 omeprazole qd w/acceptable symptom control.

Event Description

It was reported that the patient on (b)(6) 2020 - er visit for facial pain, headache and nausea/vomiting/diarrhea.Lab work and x-rays done with no concerning findings.Treated w/pain meds and oral steroids.Subject had linx implant (b)(6) 2020.On 2/11/2020 - subject spoke with pi.Symptoms had improved but still with facial pain and esophageal spasms.Pi prescribed hycosamine.(b)(6) 2020 - clinic vs.Facial pain/esophageal spasms only when lying down now.Pi prescribed steroids.Specify medication: hydrocodone/acetaminophen, prednisone, hycosamine.Updated to: torodol, benadryl, prednisone, zofran, compazine - torodol, morphine, benadryl, prednisone, zofran, compazine, hycosamine.Hospitalization: no.Dysphagia - recurrence/pattern: continuous- subject stayed on pre-op omeprazole post- linx implant.At 2 week f/u visit on (b)(6) 2020 subject was having no reflux symptoms so pi had her discontinue.Subject continued to experience heartburn and epigastric pain so on (b)(6) 2020 resumed taking omeprazole.At clinic visit on (b)(6) 2020, subject's reflux had resolved.Pi moved omeprazole dosing to evening with plans to eventually wean off it.

Manufacturer Narrative

(b)(4).New information received: hycosamine didn't help; amitryptiline started & has helped.

Manufacturer Narrative

(b)(4).Date sent: 04/03/2020.The dhr for lot: 25798 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 04/09/2020.Additional information received: reports ct abd pelvis w/contrast, er visit , ct angio chest.Medical review per medical safety officer - i reviewed the medical records associated with (b)(4).There is no correlation of the symptoms and radiology reports to any specific diagnosis.The symptoms are atypical for a patient following linx implantation and at this point in time are not consistent with any association to the linx device.

Manufacturer Narrative

(b)(4).Date sent: 04/09/2020.Additional information received: clinic visit, ct head report.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9903941
• MDR Text Key: 186753282
• Report Number: 3008766073-2020-00060
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 25798
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR