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

Model Number LXMC17

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

Patient Problem Pyrosis/Heartburn (1883)

Event Date 11/24/2021

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 manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Additional information received: this is a former relief study ((b)(6)) subject (id (b)(6)).Study is closed so this was not reported through the clinical study.Research scientist was contacted by site coordinator via telephone" search of ecm could not locate study number.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 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? will the device be returning for analysis? if yes to whom should a shipper kit be sent to (please provide full name and address of the shipper kit)?.

Event Description

It was reported that the linx was removed due to ongoing reflux.At the same time as the linx explant, the sleeve subject was converted to a roux-en-y (gastric bypass).

Manufacturer Narrative

(b)(4).Date sent: 2/1/2022.Additional information was requested, and the following was obtained: 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? answer = ph test was not performed: upper gi series was device was initially effective recurrent reflux began aug 30 2021.

• 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: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13087337
• MDR Text Key: 282772282
• Report Number: 3008766073-2021-00268
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

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: 04/17/2022
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 19823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 86 KG