MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 16 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM16

Device Problem Unintended Movement (3026)

Patient Problems Erosion (1750); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.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.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.Clarification of the event is needed.Did the patient have a re-current hiatal hernia or was there erosion of the device? what was the implant date of the linx device? what was the explant date of the linx device? what is the product code for the linx device? what is the lot number? hospital name?.

Event Description

It was reported that the linx was removed due to stomach herniating through it.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was received: did the patient have a re-current hiatal hernia or was there erosion of the device? no.Erosion of the device.No device failure.Slipped into the hiatus so surgeon removed.What was the implant date of the linx device? (b)(6) 2019.What was the explant date of the linx device? (b)(6) 2019.What is the product code for the linx device? lxm16.What is the lot number? 19587.Please provide the status of the device.Disposed of.The dhr for lot 19587 was reviewed.No ncs, reworks, or defects related to the pc were found.

• Brand Name: LINX 1.5T 16 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8522979
• MDR Text Key: 142224121
• Report Number: 3008766073-2019-00317
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

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 Expiration Date: 03/16/2022
• Device Catalogue Number: LXM16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 05/02/2019
• Patient Sequence Number: 1