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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot number was provided therefore a device history could not be done.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a linx device was explanted.The representative will call back with additional information.

Manufacturer Narrative

(b)(4).Date sent: 01/08/2021.Additional information received: reason for linx removal was of postop constant dysphasia and patient could not handle postop diet restrictions.Prior to linx placement, did the patient have an egd, ph, and manometry studies done? unknown.On what date did the implant take place? unknown.On what date did the explant take place? (b)(6) 2020.Were there any intra-operative complications during implant? no.

Manufacturer Narrative

(b)(4).Date sent: 2/2/2021.Device analysis: it was reported that the product code was unknown and the analysis site received a 15-bead linx device associated under this complaint for analysis.The 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.It could not be determined what may have cause the reported event.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: what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? was the device found in the correct position/geometry at the time of removal?.

• 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: 10991873
• MDR Text Key: 220957743
• Report Number: 3008766073-2020-00192
• 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,Followup
• Report Date: 11/16/2020

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?: 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: 01/20/2021
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 12/14/2020; 01/20/2021
• Supplement Dates FDA Received: 01/08/2021; 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention