MAUDE Adverse Event Report: JOHNSON & JOHNSON /ETHICON ENDO-SURGERY, INC. LINX; LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING

Device Problems Nonstandard Device (1420); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 09/01/2020

Event Type  Injury  

Event Description

Torax ethicon (was torax) linx anti reflux device implanted (b)(6) 2016.Received recall notice 9/2018.Gerd returned (b)(6) 2020.Linx implant confirmed separated (b)(6) 2020 (barium swallow).Have contacted ethicon but no reply yet.Fda safety report id # (b)(4).

• Brand Name: LINX
• Type of Device: LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING
• Manufacturer (Section D): JOHNSON & JOHNSON /ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 10733232
• MDR Text Key: 213254507
• Report Number: MW5097436
• Device Sequence Number: 1
• Product Code: QJN
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 88