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

Model Number LXMC15

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

Patient Problems No Consequences Or Impact To Patient (2199); Bowel Perforation (2668); No Code Available (3191)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the manufacturing records 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.Does the surgeon believe that the bowel perforation was not related to the linx device?.

Event Description

It was reported that the patient had a linx implanted on (b)(6) 2019, due to gerd.At the time of the procedure, the patient has a bowel perforation, which was unrecognized at the time of the procedure.It wasn't known if the patient stayed in the hospital for observation or was discharged.The patient returned, post op, with bowel leakage and infection.The doctor performed an explant on (b)(6) 2019, to remove the linx device, as a precautionary measure, so as not to introduce an additional foreign body in the patient, while the bowel perforation was resolved and healed.

Manufacturer Narrative

(b)(4).Date sent: 01/22/2020.H10: corrected data: updated h6.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was received: does the surgeon believe that the bowel perforation was not related to the linx device? correct! the surgeon said the bowel perforation was not related to the linx device.He believes the bowel perforation occurred on initial entry into the abdomen with the trocar.This was a robotic hiatal hernia repair with linx.The trocars that were used in the case were competitive trocars.H10: corrected data: upon review of the information received, it was concluded that this event does not meet the defined criteria for a reportable event and will be considered not reportable.H1: mdr decision ¿ not reportable.

• 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: 9575848
• MDR Text Key: 174670744
• Report Number: 3008766073-2020-00011
• 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,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Patient Sequence Number: 1