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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Pyrosis/Heartburn (1883); Vomiting (2144); Hernia (2240)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown; captured as awareness date.Unknown the exact date.Implant year was 2015.Additional information received: patient indicated that in her x-ray the device appears to be broken.Patient asked how soon she would need to have the device removed and if the pieces would migrate to different parts of her body.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: some of the below information should be on your linx implant card: what was the exact date of implant? what is the product code? what is the lot number of the device? the remaining questions could be for your surgeon.Could we please reach out to your surgeon and ask the follow up questions? if yes, please provide a name and email address for the surgeon.What was the date of the imaging(x-ray) which showed the discontinuous linx? if available, please share a copy of this imaging.Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? if yes, when is the device going to be removed? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? 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 started having upper gi issues over the past six or so months, patient experiencing re-occurring heart burn, acid reflux and vomiting.Patient went in for a scope and the doctor seemed to think that the device was intact.Patient had an x-ray over the last two weeks where it can be seen that the device appears to be broken.Patient is requesting information about migration of the broken device.

Manufacturer Narrative

(b)(4).Date sent: 12/14/2021.Additional information received: (b)(6).

Manufacturer Narrative

(b)(4).Date sent: 3/25/2022.Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.Additional information received: female x-ray received.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Op notes attached.

Manufacturer Narrative

(b)(4).Date sent: 4/21/2022.Photo analysis: as per medical safety officer: single view chest xray demonstrates a discontinuous linx device located below the diaphragm.The mechanism/cause of failure cannot be determined from the provided image.The device is within 2018 linx recall product bounding based on the implant year on (b)(6) 2016.The device is affected by 2018 linx recall.

Manufacturer Narrative

(b)(4); date sent: 12/4/2023.

• 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 55126 ; 6107428552
• MDR Report Key: 12711714
• MDR Text Key: 281668910
• Report Number: 3008766073-2021-00222
• 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: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female