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

Catalog Number LXMC15

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the manufacturing record evaluation could not be performed.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? response: no additional information available.

Event Description

It was reported that the doctor explanted the linx device due to recurrent reflux.The patient did not have an autoimmune disease.The patient was not currently taking steroids or immunization drugs.A hiatal/crural was done at the same time of implant.It is unknown if the device was in the correct position/geometry at the time of removal.A fundoplication was done after the linx was removed.There were no intra-operative complications.

Manufacturer Narrative

(b)(4).Date sent: 09/16/2019.Device analysis: 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.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The lot number is unknown, therefore no dhr review could be performed.

• 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: 8604167
• MDR Text Key: 144849284
• Report Number: 3008766073-2019-00342
• 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: 04/25/2019

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 Catalogue Number: LXMC15
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 09/16/2019
• Patient Sequence Number: 1