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

Catalog Number LXMC17

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

Patient Problems Pain (1994); Hernia (2240); Abdominal Distention (2601); No Code Available (3191)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/27/2019.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? unknown.What is the lot number of the linx device? unknown.When using the linx sizing device what technique was used to determine the size? unknown did the patient have an autoimmune disease? arthritis.Is the patient currently taking steroids / immunization drugs? unknown.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? intermittent dysphagia.Depression, arthritis.How severe was the dysphagia/odynophagia before intervention? moderate.Were there any intra-operative complications during implant? na.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 gastric pain and bloating? no.Was the device found in the correct position/geometry at the time of removal? recurrent hiatal hernia identified at time of removal so gej with linx had migrated upward.

Event Description

It was reported that post-implant of an lxmc17 the patient experienced gastric pain and bloating.The device was explanted on (b)(6) 2019.There were no patient issues with the procedure.

• 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
• Manufacturer Contact: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 9128553
• MDR Text Key: 162815215
• Report Number: 3008766073-2019-00480
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2019

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 Catalogue Number: LXMC17
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR