MAUDE Adverse Event Report: TORAX MEDICAL LLC LINX REFLUX MANAGEMENT SYSTEM; REFLUX MANAGEMENT SYSTEM/ IMPLANT, ANTI-GASTROESOPHAGEAL

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

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

Event Date 09/11/2018

Event Type  malfunction  

Event Description

Linx device explanted due to pre-op diagnosis of weight loss and impaction.Implant sent to pathology for gross analysis.Diagnosis or reason for use: gerd.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: REFLUX MANAGEMENT SYSTEM/ IMPLANT, ANTI-GASTROESOPHAGEAL
• Manufacturer (Section D): TORAX MEDICAL LLC; shoreview MN 55126
• MDR Report Key: 7910498
• MDR Text Key: 122000028
• Report Number: MW5080132
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 63