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

Model Number LXMC14

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 7/28/2020.Date of event: only event year is known: 2020.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that the patient had lapband surgery that was converted to sleeve gastrectomy due to band slippage in 2016.Linx with hernia repair using 14 bead device (b)(6) 2019.The patient had chest pain three months post-op treated with a medrol dose pack.The patient improved but is now complaining of dysphagia and chest pain with solid food for the last three weeks.The patient is able to eat, but it hurts to eat.Repeat esophagram looks the same.The doctor gave the patient a medrol dose pack, but there was no improvement this time.Patient has not required a revision surgery or an explant.There were no patient consequences reported.

• Brand Name: 1.5T LINX, 14B
• 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, MN ; 6107428552
• MDR Report Key: 10332299
• MDR Text Key: 201691254
• Report Number: 3008766073-2020-00107
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2020

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 Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR