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

Lot Number 3942

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Erosion (1750)

Event Date 06/10/2021

Event Type  malfunction  

Event Description

Patient had a linx reflux management system placed eight years ago.Patient required surgery for the removal of the linx device because it eroded the esophagus.Torax medical, inc.Will evaluate the device once returned to their facility.

• Brand Name: LINX
• Type of Device: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
• Manufacturer (Section D): TORAX MEDICAL, INC.; ethicon srv rd4188 lexington avenue north; shoreview MN 55126
• MDR Report Key: 12057125
• MDR Text Key: 258059982
• Report Number: 12057125
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3942
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27740 DA
• Patient Weight: 56