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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problems Pyrosis/Heartburn (1883); No Code Available (3191)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Maude report # mw5091745.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported, "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 denial to pay.".

Manufacturer Narrative

(b)(4).Date sent: 03/31/2020.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Additional information received: device was removed on (b)(6) 2019.Device was discarded by the hospital.

Manufacturer Narrative

(b)(4).Date sent: 05/28/2020.Additional information was requested, and the following was received: what was the condition of the device when it was removed? was there anything unusual noted? response: i spoke with the surgeon on 5.12.20 and he said there was nothing unusual about the device¿s condition upon removal other than the discontinuous nature which was already known and the primary reason the device was explanted.There was nothing else unusual to report.

Manufacturer Narrative

(b)(4).Date sent: 09/23/2020.Additional information received: the patient underwent a laparoscopic nissen fundoplication as the surgeon was concerned about scar tissue at the time of device removal.He had more difficulty initially following this procedure but now the gerd symptoms have resolved.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9611333
• MDR Text Key: 175699250
• Report Number: 3008766073-2020-00015
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Patient Sequence Number: 1