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

Catalog Number LXMC15

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: how is the patient doing since explant? great.What is the lot number for the linx device? 23895.Was ph testing performed prior to explant to confirm recurrent reflux? no, not necessary.After implant, was the device initially effective in controlling reflux? yes.When did the recurrent reflux begin? it wasn¿t removed due to recurrent reflux.It was removed due to sub-sternal pain.Is this device available to be returned? no.

Event Description

It was reported that the patient had a 15-bead clasp linx device implanted on (b)(6) 2019, due to gerd and acid reflux.After the procedure, the patient reported that they sneezed and had a sharp stabbing substernal pain.An upper gi study was performed, and everything looked normal.The patient still wanted the device removed.The doctor performed an explant on (b)(6) 2019.Didn't indicate any negative observations then performed a gastric bypass after removing the linx device.

Manufacturer Narrative

(b)(4).Date sent: 09/26/2019.The dhr for lot 23895 was reviewed.No ncs, reworks, or defects related to the complaint were found.

• Brand Name: 1.5T LINX, 15B
• 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: 9081280
• MDR Text Key: 161093170
• Report Number: 3008766073-2019-00455
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

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 Expiration Date: 10/26/2022
• Device Catalogue Number: LXMC15
• Device Lot Number: 23895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1