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

Model Number LX12

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

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

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

Device analysis in process.

Event Description

Following a laparoscopic anti-reflux procedure, a patient required mri(s) 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) 2010 by dr.(b)(6).Uneventful device explant on (b)(6) 2017 due to need for multiple unrelated mri scans by dr.(b)(6).Device found in correct position/geometry at the time of removal.Fundoplication performed immediately after explant.

Manufacturer Narrative

Addition of exposure to mri scan to patient narrative.Addition of device evaluation results.Addition of device evaluation.

Event Description

Following a laparoscopic anti-reflux procedure, a patient required mri(s) 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) 2010 by dr.(b)(6).Patient was exposed to mri field for her back approximately 2 years prior to explant.Uneventful device explant on (b)(6) 2017 due to need for multiple unrelated mri scans by dr.(b)(6).Device found in correct position/geometry at the time of removal.Fundoplication performed immediately after explant.

• 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: jessica ahlborn ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6640586
• MDR Text Key: 77554502
• Report Number: 3008766073-2017-00058
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/26/2014
• Device Model Number: LX12
• Device Lot Number: 2232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2010
• 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: 51 YR