MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. LINX REFLUX MANAGEMENT SYSTEM; LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Nausea (1970); Dysphasia (2195); Hematemesis (4478)

Event Date 10/12/2020

Event Type  Injury  

Event Description

Surgery for gerd and hiatal hernia took place at (b)(6) on (b)(6) 2020 inserting linx device.Pt dc'd (b)(6) 2020.Pt readmitted with serious internal bleeding on (b)(6) 2020.After 2 blood transfusions pt dc'd on (b)(6).Pt struggled w/ dysphasia, nausea and vomiting.Pt readmitted to hospital on (b)(6) 2020 after vomiting blood - gi bleeding.Egd procedure showed that 2 beads from the linx device has eroded into esophagus.Egd procedure showed that at least 2 beads from the linx device had eroded into the lumen at ge junction.Fda safety report id# (b)(4).

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 10975607
• MDR Text Key: 220692285
• Report Number: MW5098256
• Device Sequence Number: 1
• Product Code: QJN
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR
• Patient Weight: 57