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

Model Number LXMC14

Device Problem Break (1069)

Patient Problems Pyrosis/Heartburn (1883); Failure of Implant (1924); Scar Tissue (2060)

Event Date 11/01/2021

Event Type  Injury  

Event Description

I recently had a defective linx device removed from my esophagus, a device that broke less than 3 years after implantation, resulting in a return of significant reflux.I was forced to undergo another surgery, resulting in scarring, loss time at work, pain etc.Fda safety report id # (b)(4).

• Brand Name: LINX
• Type of Device: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
• Manufacturer (Section D): J&J / TORAX MEDICAL, INC.
• MDR Report Key: 14601747
• MDR Text Key: 293550975
• Report Number: MW5110107
• 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: Patient
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White