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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Pyrosis/Heartburn (1883)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/21/2020.Date of event: only event year known: 2020.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information will be requested.If a response is received a supplemental medwatch will be sent.

Event Description

It was reported that the patient was implanted with linx about 2 years ago.Patient returned to office with recurrent gerd symptoms.Egd showed eroded linx.Surgeon will be referring the patient to mayo clinic for endoscopic removal, date to be determined.

Manufacturer Narrative

(b)(4), date sent: 10/27/2020.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Additional information was requested, and the following was obtained: the patient was referred to mayo clinic and had the device removed.The exact explant date is unknown.The patient is doing well.

• 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: 10560294
• MDR Text Key: 207733160
• Report Number: 3008766073-2020-00146
• 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: 08/31/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention