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

Model Number LXMC14

Device Problem Nonstandard Device (1420)

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: (b)(6) 2020.Date of event: only event year known: 2020.Additional information received: confirmed with the coordinator that this is not a discontinuous device but was part of the recall.Esophagram done before explant not cxr.Positive ph bravo study post implant on (b)(6) 2017.Had egd done (b)(6) 2019 and (b)(6) 2020.Device is lxmc-14.Lot 9408 and serial # (b)(4).Removal date (b)(6) 2020.Implanting surgeon dr.(b)(6).Explanting surgeon dr.(b)(6).Date of onset of symptoms (b)(6) 2016 some difficulty swallowing from time to time especially with breads.Or too much water.6-2019 ct done for abdominal pain and continued difficulty swallowing was the device replaced or a fundoplication done or a dor fundoplication was done same day as removal.Any mris done since the device was implanted back in 2016? yes one of the brain (b)(6) 2019 but it was with the 1.5 tesla as that is what his was permitted how¿s the patient doing now? was kept npo for 12 hours after removal, esophogram was done the following day.We have talked to him once since.He is doing as expected.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported dysphagia and abdominal pain? was the device found in the correct position/geometry at the time of removal? (b)(4).

Event Description

It was reported that a linx device was recently removed and she understood it was part of the recall.Implant date of (b)(6) 2016.

Manufacturer Narrative

(b)(4).Date sent: 03/31/2020.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 available, please share the results.Positive ph bravo study post implant on (b)(6) 2017.Had egd done (b)(6) 2019 and (b)(6) 2020.When using the linx sizing device what technique was used to determine the size? not noted.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? not noted.How severe was the dysphagia/odynophagia before intervention? severe enough to request removal.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 removal of the device other than the reported dysphagia and abdominal pain? slight smooth esophageal narrowing noted at level of linx on esophagram.Was the device found in the correct position/geometry at the time of removal? yes.Have the symptoms resolved since the device was explanted? yes.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.The visual analysis was consistent with an explanted device.The 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 9408 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9799431
• MDR Text Key: 185659822
• Report Number: 3008766073-2020-00040
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2019
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 9408
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 03/31/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention