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

Model Number LXMC14

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The dhr for lot 24873 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? yes egd, manometry.The results are shown in the file.When using the linx sizing device what technique was used to determine the size? visual + 3 above magnet pop.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? not sure when this is in reference to.Pt was not on steroids or immunomodulators at the time of surgery.She did have 2 rounds of steroids (5 days each) to treat her dysphagia.She was not on steroids at the time of her dilation.Did the patient have any pre-existing dysphagia, or other conditions (other than gerd)? she did have preexisting dysphagia, other conditions osa, osteoarthritis, depression and anxiety.How severe was the dysphagia/odynophagia before intervention? moderate.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.Were there any other contributing factors that led to the dilation of the device other than the reported dysphagia? no.Was the device found in the correct position/geometry at the time of the dilation? yes.Was the patient take prescribed steroids from the doctor while the linx device was implanted? it was stated the patient suffered from other conditions.Osa, osteoarthritis, depression and anxiety.Were these conditions the patient suffered while the linx device was implanted? answer = both rounds of steroids were after surgery.The first was 9 weeks post op, the second was 11 weeks post op.Dilation was 13 weeks post op.In reference to the pre-existing conditions, since those conditions existed before the patient had the linx implanted, the conditions still exist after the implant.

Event Description

The following information was reported: start date: (b)(6) 2020; alert date:(b)(6) 2020; model: lxmc14; device lot number: 24873; date of surgery: (b)(6) 2020.Adverse event term: dysphagia requiring dilation.Patient identifier: (b)(6); sex: female; age (at time of consent): (b)(6) years old.Additional event details site awareness date: 18 aug 2020; severity: moderate; is the adverse event serious? no.Death: no.Life-threatening illness or injury: no; permanent impairment of a body structure or a body function: no; required in-patient hospitalization or prolongation of existing hospitalization: no; resulted in medical or surgical intervention: no; led to fetal distress, fetal death or a congenital abnormality or birth defect: no; dilation performed: yes.Indicate type of dilation? mechanical.Date of dilation: (b)(6) 2020.Diagnostic intervention: no; diagnostic imaging: no; drug therapy: no; observation: no; linx explant: no; other surgical intervention: no; other intervention/treatment: no; outcome: not recovered/not resolved.Did this event result in the patient¿s discontinuation of the study? no.

• 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: 10828916
• MDR Text Key: 215915712
• Report Number: 3008766073-2020-00170
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2023
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 24873
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR