MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Model Number LXMC14

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524)

Patient Problems Pyrosis/Heartburn (1883); Insufficient Information (4580)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown, captured as awareness date.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Photo was provided for review by ethicon medical safety officer.Following are their observations: "i reviewed a photograph of a computer screen showing an ap and lateral plain abdominal xray of the patient referred to in this complaint.There were 2 images from the (b)(6) 2021 which showed a discontinuous linx device as evident by a c-shape and absence of the expected annular appearance".Hands on analysis of the affected device is needed to establish the mechanism/cause of failure.The dhr for lot 17192 was reviewed.No ncs, defects, or reworks related to the product complaint were found.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 symptoms lead to the discovery of the discontinuous device? when did they begin? 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?.

Event Description

It was reported there was a patient with a possible discontinuous device.No further information was reported.

Manufacturer Narrative

(b)(4).Date sent: 6/28/2021.Additional information was requested, and the following was obtained: what symptoms lead to the discovery of the discontinuous device? when did they begin? experiencing gerd.What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.You have provided this already.Was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? not to our knowledge.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? yes, on (b)(6) 2018 for back issues but states he told them it had to be the 1.5 tesla.Did the patient have any other surgeries in the area? the patient had a cholecystectomy on (b)(6) 2018 and more recent the patient underwent spine surgery.The patient had to have f/u films as part of the f/u from spine surgery and on (b)(6), there is clear radiographic documentation that his device has opened up and is in a ¿c-shape¿.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? we would like to remove the device and replace it.The patient is reluctant to have surgery again.The patient stated that he would reach out to us when he is ready to proceed.When and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? yes.When and if the linx device is removed, may we ask that the device be returned for analysis? yes.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11939196
• MDR Text Key: 257572745
• Report Number: 3008766073-2021-00108
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 17192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention