MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT

Model Number LS13

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2016

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient required a mri for unrelated causes leading to linx device explant.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and linx device implantation date (b)(6) 2015 by dr.(b)(6) at (b)(6) hospital.-uneventful device explant on (b)(6) 2016 due to need for an unrelated mri scan.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: daniel hoseck ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6209169
• MDR Text Key: 63410729
• Report Number: 3008766073-2016-00109
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005028
• UDI-Public: 00855106005028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 06/26/2017
• Device Model Number: LS13
• Device Lot Number: 4911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 50 YR