MAUDE Adverse Event Report: TORAX MEDICAL, INC. LX16; ANTI-REFLUX IMPLANT

Catalog Number LX16

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pyrosis/Heartburn (1883); Vomiting (2144)

Event Date 01/10/2019

Event Type  Injury  

Event Description

A linx device was implanted on (b)(6) 2015 and removed on (b)(6) 2019 due to the patient receiving an mri.This linx was the old version that supported just tesla 0.7.The magnetism got lost and the patient got back his reflux problems and vomiting.So they explanted it on (b)(6) 2019.

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.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 of this complaint? what is the lot number? what was the date of the imaging 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? 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?.

Manufacturer Narrative

(b)(4).Date sent: 3/16/2022.Investigation summary: a partial device (12 beads) was returned in one piece with 5 exposed links, which suggests demagnetization/depolarization of magnets.Due to this depolarization/demagnetization, the exposed links did not exhibit separation force during tensile testing.See force test results for details.All other bead separation forces and average link length were within the specification.Therefore, the device investigation suggests that the device was likely damaged due to exposure to mri higher than labeling.Note that this device was mri conditional for static magnetic field of 0.7tesla per torax ifu; however, the customer reported the device being exposed to higher mri strength.The device contains magnets.The linx device is considered mr conditional.Exposure to an mri environment above the mr conditional guidelines could cause serious injury to the patient and/or interfere with the magnetic strength and the function of the device.The device is not safe when exposed to mri magnetic fields greater than 0.7 t.In the event alternative diagnostic procedures cannot be used and mri is required beyond the mr conditional guidelines, the linx device can be safely removed utilizing a laparoscopic technique that does not compromise the option for traditional anti-reflux procedures.A manufacturing record evaluation was performed for the finished device batch number 7758, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 2/15/2022.Additional information was requested, and the following was obtained: what was the product code and lot number of the linx device that was explanted on (b)(6) 2019? lot number is lx16, lot: 7758, sn: (b)(6).When was the mri taken and what strength was the mri? on (b)(6) 2018, 1.5 tesla.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.

• Brand Name: LX16
• 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: 13251715
• MDR Text Key: 283764220
• Report Number: 3008766073-2022-00005
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2019
• Device Catalogue Number: LX16
• Device Lot Number: 7758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 01/24/2022; 03/04/2022
• Supplement Dates FDA Received: 02/15/2022; 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention