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 Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 01/14/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Exact date unknown.Month of date of event unknown.Assumed the first month of the year.No lot number was provided therefore a device history could not be done.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 product code? what is the lot number? is the device available for return for analysis? when was the date of implant? when was the date of explant? are there future plans to remove the remaining bead? why did the surgeon not remove all the beads during the initial explant? did the linx device erode while it was implanted? if yes for erosion, what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.Are pictures or videos available? how many beads eroded? where were the eroded beads positioned? which best describes the device removal approach? endoscopically removed the eroded beads initially & laparoscopically removed the device at a later date.Endoscopically removed the eroded beads & laparoscopically removed the device the same day.Endoscopically removed the entire device.Laparoscopically removed the entire device.Was the patient stented? what is the current condition of the patient? where exactly is the bead located in the abdomen? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 the patient is undergoing inpatient treatment.He had an implanted linx device, which has since been explanted.According to the treating physician, a magnetic ball of the device is intrabdominal.The radiologists need a confirmation that despite the presence of the metal ball an mri of the skull can be performed.

Manufacturer Narrative

(b)(4); date sent: 11/22/2022.Additional information was requested, and the following was obtained: what is the product code? what is the lot number? is the device available for return for analysis? when was the date of implant? when was the date of explant? are there future plans to remove the remaining bead? why did the surgeon not remove all the beads during the initial explant? did the linx device erode while it was implanted? if yes for erosion, what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.Are pictures or videos available? how many beads eroded? where were the eroded beads positioned? which best describes the device removal approach? endoscopically removed the eroded beads initially & laparoscopically removed the device at a later date.Endoscopically removed the eroded beads & laparoscopically removed the device the same day.Endoscopically removed the entire device.Laparoscopically removed the entire device.Was the patient stented? what is the current condition of the patient? where exactly is the bead located in the abdomen? no further information available.Have sent the email to the right address but haven¿t received a reply yet.Will get back to you as soon as i¿ll have more information.

Manufacturer Narrative

(b)(4).Date sent: 12/27/2022 h6: health effect clinical code.

• 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: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 15709861
• MDR Text Key: 302792956
• Report Number: 3008766073-2022-00213
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/07/2022; 12/27/2022
• Supplement Dates FDA Received: 11/22/2022; 12/27/2022
• 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
• Patient Outcome(s): Required Intervention