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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Consequences Or Impact To Patient (2199); Hernia (2240); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2019.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.On what date was the linx device implanted? on what date was the additional surgery to repair the hernia? it was reported that the linx device may have been a lxmc16.Can you please confirm if this is correct? if the linx device was not a lxmc16, was is the correct product code? what is the lot number for the linx device? what was the size of the hernia that was repaired during the original implant procedure? how was the recurrent hernia diagnosed? did the patient have recurrent symptoms? if yes, please share what symptoms they were experiencing.It was reported that in approximately 6 weeks the patient will have the linx replaced with a wrap? has this surgery been scheduled? if yes, what is the surgery date? when the linx device is removed we are requesting it be returned for evaluation.Can you please provide contact name and mailing address for the return kit?.

Event Description

It was reported that unfortunately the patient had a large paraesophageal hernia recur with his linx up in his chest after about 3 weeks.Repaired with interrupted 0 ethibond pledgeted suture and mesh.The patient is stable and unobstructed.Tentative plan per the surgeon is to wait another three weeks, get the patient six weeks out from surgery and redo a possible relaxing incision and likely replace linx with a wrap to provide more bulk in the abdomen.It is unknown what linx size was used for this patient.I believe lxmc16.

Manufacturer Narrative

(b)(4).Date sent: 01/15/2020.H10: corrected data: h1: mdr decision: not reportable.H6: patient code updated.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Additional information received: i spoke with the surgeon again.The patient did not have a second procedure.The patient is very happy with the linx procedure.Dr.Jones emailed dr.Bell for advice.The patient was experiencing defib.He is going to continue to monitor patient but at this time there are no plans for additional surgery.

• 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: 9574345
• MDR Text Key: 174858176
• Report Number: 3008766073-2020-00007
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• 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: 01/10/2020
• Patient Sequence Number: 1