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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); No Code Available (3191)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 10/30/2020.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.The lot number was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: can you please provide further detail as to the extract of the linx band.Did the explant procedure take place? if yes, on what date was the band explanted? (b )(6) 2020 do you have the linx product code (model number), lot number and serial number (if applicable)? what was the reason for removal of the linx device (no issue - patient requested removal, ongoing dysphagia, ongoing gerd symptoms, etc.)? dysphagia /pain.If dysphagia, how severe was the dysphagia/odynophagia before intervention (mild, moderate or severe)? did the dysphagia improve after the device was implanted initially? unknown.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.When was the linx device implanted? were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Was the device found in the correct position/geometry at the time of removal? yes.Was a new linx placed after this one was removed? no.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: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? on what date did the implant take place? what is the product code for the linx device that was removed? 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 any pre-existing dysphagia or other conditions (other than gerd)?.

Event Description

It was reported that a linx removal procedure will happen today at 10am.This is all the information known.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN ; 6107428552
• MDR Report Key: 10762822
• MDR Text Key: 213881221
• Report Number: 3008766073-2020-00163
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 10/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1