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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Vomiting (2144); Blood Loss (2597); No Code Available (3191)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: unknown, assumed 1st day of month that complaint was reported.Attempts are being made to obtain consent from the patient to allow us to follow-up with the surgeon to ask some additional questions.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the patient she had a linx device implanted on (b)(6) 2018.The doctor prescribed hycosamine and valium for pain.The patient reported that she couldn't hold down fluids from the beginning, after the procedure.On (b)(6) 2018.The patient reported an arterial bleed in the lower curvature of stomach.Patient has been belching and bringing up food.The patient was gone back to her surgeon on (b)(6) 2018 and an edg and dilated her esophagus.The patient is continuing to experience vomiting.The patient is scheduled to see her doctor in the near future to discuss treatment options.

Manufacturer Narrative

(b)(4).Date sent: 02/01/2019.Additional information requested, and the following was received: yes, you may contact (b)(6).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.How is the linx associated with the current symptoms? how was the bleeding diagnosed and treated? what caused the bleeding? in relation to the medications prescribed, how are they associated with the linx?.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8213576
• MDR Text Key: 131968125
• Report Number: 3008766073-2019-00229
• 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: other
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 02/01/2019
• Patient Sequence Number: 1