MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Model Number LXMC15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Pain (1994); Hernia (2240); No Code Available (3191)

Event Date 10/29/2020

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.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.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.What was the exact implant date? what is the lot number for the linx device? was ph testing performed prior to explant to confirm recurrent reflux? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin? if information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that the patient had the linx device implanted in (b)(6) 2019 and five months later began to experience heavy gastric pain.The patient had an upper gi study performed and a ph study that reflected mild reflux.The gastric emitting study was also done, and it was normal.A ct scam was done, and it didn't reflect much of a hiatal hernia.The patient was not exposed to an mri.The device was explanted on (b)(6) 2020.

Manufacturer Narrative

(b)(4).Date sent: 12/14/2020.Additional information was requested, and the following was received: what was the exact implant date? on (b)(6) 2019.What is the lot number for the linx device? 24044.Was ph testing performed prior to explant to confirm recurrent reflux? yes, demeester score was 35.After implant, was the device initially effective in controlling reflux? yes.When did the recurrent reflux begin? on (b)(6) 2019.The dhr for lot: 24044 was reviewed.No defects, reworks, or ncs related to the product complaint were found.Mfg date: 11/14/2018, exp date: 11/14/2022.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10843029
• MDR Text Key: 216348080
• Report Number: 3008766073-2020-00180
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: 10/30/2020

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: 11/14/2022
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/14/2020
• Patient Sequence Number: 1