MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Catalog Number LXMC13

Device Problem Defective Component (2292)

Patient Problems Inflammation (1932); Vomiting (2144); Discomfort (2330); No Code Available (3191)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/23/2019.Additional information: patient is having problems with her esophagus.The food gets stuck down at the linx.He stated that the doctor explained that it is inflamed and there is scar tissue, and this is not allowing the food to pass.The doctor feels it is defective and not working the way it should.No further explanation was provided by the doctor as to what this means.Mr.Orr will call back an update us as to what the next steps are for his daughter after her follow-up appointment with dr.(b)(6) in (b)(6) (exact date of appointment could not be provided at this time as he was not at home).He stated that they need to find out something because she continues to have vomiting episodes and heartburn that keeps her in the bed.

Event Description

It was reported that the patient had a linx implanted on (b)(6) 2017 due to acid reflux.The daughter continued to have mild acid reflux with the linx implant.The implant surgeon stretched the esophagus during a post op visit, which allowed the acid reflux to subside.Nine months post op, the daughter had worsening acid reflux.The original surgeon had moved to a different location and the daughter was tested by a different gastro intestinal doctor.The second doctor performed an upper gi endoscopy, esophageal test, pill test and x-rays, and determined that the linx ring didn't seem to be working and the area where the linx was placed was inflamed.The daughter currently looking for options for explant but nothing has been scheduled.No other information is known at this time.

Manufacturer Narrative

(b)(4).Date sent: 12/12/2019 additional information received: per the patient¿s father, ¿the expansion was done and per the surgeon the device is working as prescribed.If she has any issues following the expansion, they were to follow back up with the surgeon.The patient ended up being admitted to the hospital which was not related to the linx device due to not being able to have a bowel movement.6-8 inches of her colon was impacted.They went in from the bottom end and did some samples and then went in from the top and were able to get through the blockage and the doctor squirted some water through.She was discharged on a liquid diet and will be seeing a digestive specialist soon.So far she is doing well and no issues with the linx but still is on the liquid diet.¿ the patient¿s father will contact us if she develops any issues or symptoms related to the linx.

Manufacturer Narrative

(b)(4).Date sent: 10/09/2019.The dhr for lot 12485 was reviewed.No ncs, reworks, or defects related to the product complaint were found.

Manufacturer Narrative

(b)(4).Date sent: 11/12/2019.Additional information received: implant is working too well.There is enough scar tissue that is not allowing the device to open enough to allow the food to go through.The surgeon has scheduled an appointment for (b)(6) to expand the ring by 15-18 cm.Patient will follow back up with the surgeon a couple weeks after to see if the expanding worked.If not, they will schedule a surgery to remove the current ring and replace with a larger one.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9103948
• MDR Text Key: 162643892
• Report Number: 3008766073-2019-00470
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Catalogue Number: LXMC13
• Device Lot Number: LOT 12485
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 09/24/2019; 10/17/2019; 12/09/2019
• Supplement Dates FDA Received: 10/09/2019; 11/12/2019; 12/12/2019
• Patient Sequence Number: 1
• Patient Age: 61 YR