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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Defective Component (2292)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the manufacturing record evaluation could not be performed.The following information was requested, but unavailable: date of implant? implanting physician? device size? device model? device lot number? device serial number (if applicable)? does the patient have any of the following? autoimmune disease, allergy to metals/ metal implants.Currently taking steroids / immunization drugs.What was the reason for removal of the linx device? what were the complications that led to the removal of the device? what is meant by, ¿the device was non-functioning when removed?¿ pre-implant information: were any diagnostic test performed pre-implant? e.G manometry barium swallow, ph testing, egdif so, please describe results.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)?if yes, please describe.Implant information: were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? reason for removal: please provided details of the reason for removal of the linx device.Did the patient's gerd symptoms improve after explant of device? if the patient experienced gerd, what was the severity? mild/moderate/severe please describe any additional diagnostic testing or intervention performed prior to removal, including the date.Explant information date of explant? was the device found in the correct position/geometry at the time of removal? if no, please describe observations please explain any notable observations during explant: was a replacement linx device used? what was the lot number of the replacement linx? was a fundoplication performed at the time of device removal?.

Event Description

It was reported that the patient had a unknown link implanted at a different hospital facility, encountered unknown complications with the link device and was admitted to the caller's facility to have the linx explanted.The doctor removed the unknown link device on (b)(6) 2019 and performed an esophagogastric fundoplasty, in place of a new link implant.The doctor indicated the device was non-functioning when removed from the patient.The patient is currently being monitored, in-patient.

Manufacturer Narrative

Pc-(b)(4).Date sent: 08/14/2019.Device analysis: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The device lot number is unknown; therefore, the device history record could not be reviewed.

Manufacturer Narrative

(b)(4).Date sent: 01/02/2020.Additional information: the device was implanted at university medical center (texas tech) and dr.Eggl was the implant and explant surgeon.The device was explanted at covenant medical center.

• 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: 8811243
• MDR Text Key: 151732970
• Report Number: 3008766073-2019-00388
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2019

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: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 08/12/2019; 12/12/2019
• Supplement Dates FDA Received: 08/14/2019; 01/02/2020
• Patient Sequence Number: 1