MAUDE Adverse Event Report: ETHICON / TORAX MEDICAL, INC. ETHICON LYNX ANTI REFLUX BEAD; IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX

Model Number LOG5261988

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Failure of Implant (1924)

Event Date 05/16/2022

Event Type  malfunction  

Event Description

The patient is a (b)(6) woman who is a few years out from repair of a hiatal hernia and placement of a sphincter augmentation device for severe reflux disease.About 3 years postop from this, she developed recurrence of symptoms.There is no pain or other episodes associated with the return of her symptoms.Postop follow up showed a discontinuous device.Company was informed and per protocol, the device was removed.During surgery, the device was located just above the ge junction, which is the normal location.Noted the device had become discontinuous posteriorly.Due to the posterior discontinuation of the device, the surgeon was unable to place any sort of suture, penrose or any other device and so the capsule was unable to be removed.To avoid esophageal injury, the capsule was left and patient underwent anterior fundoplication.A metallic ring device lies at the level of the gastroesophageal junction and appears to encompass at least 270 degrees of a cervical.The posterior aspect of the ring is open.The entire reflux device esophageal ring appears disrupted posteriorly.Fda safety report id# (b)(4).

• Brand Name: ETHICON LYNX ANTI REFLUX BEAD
• Type of Device: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
• Manufacturer (Section D): ETHICON / TORAX MEDICAL, INC.
• MDR Report Key: 14488723
• MDR Text Key: 292733679
• Report Number: MW5109883
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/20/2022

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: Health Professional
• Device Model Number: LOG5261988
• Device Lot Number: 18766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White