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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 08/13/2019

Event Type  Injury  

Event Description

In (b)(6) of 2016 a linx device manufactured by torax medical was implanted to treat gerd at (b)(6) and while in (b)(6), after other attempts to treat gerd such as ppi's had failed.While working in (b)(6) in (b)(6) of 2019, i noticed my gerd symptoms had returned.On (b)(6), i received a positive diagnosis through a test at university of (b)(6) at (b)(6) that the linx had failed and info that my device was part of a recall.Torax medical had agreed to pay for a replacement device but not the surgery or other costs associated with the operation.Because of this, i postponed the surgery for several months and attempted to manage my gerd symptoms with modifications to my diet and ppi's.On (b)(6), 2019, i scheduled the surgery to have the linx removed and have a fundoplication at the university of (b)(6) health center in (b)(6).At this time, my insurance company is denying paying for the surgery.Torax medical is also denying paying for the surgery.When the linx device was removed, it was examined by the dr and he commented the device had deteriorated similar to a cheap piece of jewelry and was broken.This indicated inferior quality of material and poor mfg oversight in the construction of the linx, which resulted in premature failure.Even though the device is under recall.Torax medical does not appear to be responsible for anything other than a replacement device.This does not seem morally or ethically right for a company to be allowed to take this approach.Also, i am faced with who will pay for the device removal and fundoplication surgery, since my insurance company and torax medical are currently in a denial to pay.Fda safety report id# (b)(4).

• Brand Name: LINX DEVICE
• Type of Device: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
• Manufacturer (Section D): TORAX MEDICAL INC.
• MDR Report Key: 9491291
• MDR Text Key: 172030373
• Report Number: MW5091745
• 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: 12/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• 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: 48 YR
• Patient Weight: 83