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

Model Number LXMC15

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a linx implant, the device was rendered unsterile.They opened a new one to complete case.No patient complications.

Manufacturer Narrative

(b)(4).Date sent: 10/13/2020.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The dhr for lot 26801 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Mfg date: 03/26/2020.Exp date: 03/26/2024.

• 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: 10502093
• MDR Text Key: 206557385
• Report Number: 3008766073-2020-00141
• 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
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2024
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 26801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Patient Sequence Number: 1