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

Catalog Number LXMC15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Nerve Damage (1979); Paresis (1998)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown; captured as awareness date.No lot number was provided therefore a device history could not be done.

Event Description

Patient underwent a hiatal repair, linx implantation and an endoscopic gastroduodenoscopy with no complications noted.Postoperatively the patient has had multiple er visits and hospitalizations and ultimately was taken to (b)(6) by her daughter where vagus nerve injury was diagnosed after findings of undigested food remaining in her stomach.

Manufacturer Narrative

(b)(4).Date sent: 5/17/2021.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.

Manufacturer Narrative

(b)(4) date sent: 9/28/2021 additional information was requested, and the following was obtained: received information that indicated the surgeon reports the product code for this device is lxmc15 and the lot number is 22649.The dhr for lot 22649 was reviewed.No ncs, defects, or reworks related to the product complaint were found.D1 & d4.

Manufacturer Narrative

(b)(4).Date sent: 12/14/2021.Additional information received: one document containing an operative report and a barium swallow received.Information in document: date of implant (b)(6) 2018.Female 53 years old.Dob (b)(6) 1965.Esophagram performed (b)(6) 2018.

• 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: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 11139572
• MDR Text Key: 225778884
• Report Number: 3008766073-2021-00002
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2021

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: 08/10/2022
• Device Catalogue Number: LXMC15
• Device Lot Number: 22649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 05/17/2021; 09/14/2021; 12/06/2021
• Supplement Dates FDA Received: 05/17/2021; 09/28/2021; 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female