MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number LXMC15

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: unknown.The dhr for lot 10998 was reviewed.No ncs, reworks, or defects related to the pc were found.The lot is affected by the 2018 linx recall.Additional information received: no new info.Patient has decided she doesn¿t want it removed at this time.She has symptom control so she¿s happy.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.It was reported that the patient presented with epigastric pain following the placement of the linx device.When did the epigastric pain begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.It was reported that the patient is doing well from the gerd standpoint.Has the gerd symptoms returned? 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.It was reported that it had not been determined if the device would be removed or if the surgeon was going to continue to monitor the patient (and the patient was not really wanting it removed).Has there been a decision on what the next steps will be for this patient? will the patient be medically managed? will the device be removed? is a fundoplication planned?.

Event Description

It was reported that post implant procedure for a linx device, patient complained of epigastric pain.Barium swallow showed a discontinuous linx device.It has not been determined if the device will be removed or if the surgeon will monitor the patient.The patient is not really wanting the device removed as she is doing well from a gerd standpoint.¿patient has had intermittent symptoms of sub sternal chest pain and dysphasia since shortly after surgery that i have attributed to esophageal spasm and that have always responded to benzodiazepines.The symptoms have been very intermittent, and she will go months doing fine and then will call me complaining.I did an egd (b)(6) 2017 that was completely normal.Otherwise there has been no events, she has not had an mri, no other surgery of the upper abdomen.¿.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 9009989
• MDR Text Key: 160442688
• Report Number: 3008766073-2019-00445
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2019

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: 05/05/2020
• Device Catalogue Number: LXMC15
• Device Lot Number: 10998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1