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

Catalog Number LXMC15

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dhr for lot 14055 was reviewed.No ncs, reworks, or defects related to the pc were found.Additional information was requested, and the following was obtained: what was the date of implant? on (b)(6) 2017.Was ph testing performed prior to explant to confirm recurrent reflux? no recurrent reflux removed due to epigastric pain.After implant, was the device initially effective in controlling reflux? patient did well for 2-3mos and then developed pain, taking hydrocodone for pain.When did the recurrent reflux/epigastric pain begin? approximately 3mos after implantation.Has the reflux/epigastric pain resolved since explant? unknown at this time.Will check with the surgeon.

Event Description

It was reported that the linx device (lxmc15, lot 14055) was removed due to epigastric pain.

Manufacturer Narrative

(b)(4).Date sent: 09/12/2019.Device analysis: visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Overall, no analysis conclusions relevant to the patient experience were found.The dhr for lot 14055 was reviewed.No ncs, reworks, or defects related to the pc 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
• MDR Report Key: 8594777
• MDR Text Key: 144545072
• Report Number: 3008766073-2019-00336
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

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: 02/27/2021
• Device Catalogue Number: LXMC15
• Device Lot Number: 14055
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 09/12/2019
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 74