MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Catalog Number LXMC13

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was received: device ¿ lxmc 13 was implanted on (b)(6) 2017.Lot# - 13122.Hospital ¿ (b)(6) hospital.Symptoms prior to linx implant in 2017 ¿ regurgitation, dysphasia, and heartburn.Dr (b)(6)¿s office ordered a follow-up upper gi study in (b)(6) 2018 which showed that the linx device looked to have some separation and could be on stomach more than esophagus ¿ according to dr (b)(6).This was a study they do as part of their research protocol.Patient was asymptomatic.On (b)(6) 2019 ¿ an abdominal x-ray was ordered by (b)(6) md (gi in (b)(6) ¿ (b)(6) general hospital) based on patient dealing with symptoms of chronic constipation.The x-ray image is the one originally sent to demonstrate a potential discontinuous linx device.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.Was it confirmed that the device did migrate onto the stomach? if yes, are there images available that show the migration? if yes, please send to (b)(4).Did the patient have a hiatal hernia at the time of removal?.

Event Description

It was reported that post-implant a linx device had become discontinuous as confirmed by x-ray.This is the only information available at this time.It is unknown if there were any adverse patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 09/11/2019.Per photographic evaluation: an x-ray showing a discontinuous device was received.The linx device remains implanted and has therefore not yet been returned.The mechanism/cause of failure cannot be determined from the x-ray provided.Lot number is unknown at this time.No dhr could be performed.

Manufacturer Narrative

(b)(4).Date sent: 11/04/2019 the dhr for lot 13122 was reviewed.No ncs, reworks, or defects related to the product complaint were found.Lot 13122 is within the bounding of the 2018 linx recall.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8846751
• MDR Text Key: 152811750
• Report Number: 3008766073-2019-00408
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2020
• Device Catalogue Number: LXMC13
• Device Lot Number: 13122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2019
• Patient Sequence Number: 1
• Patient Age: 72 YR