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

Model Number LXMC13

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); No Code Available (3191)

Event Date 08/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 dhr for lot 4793 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: on what date did the implant take place? (b)(6) 2015.What is the product code for this complaint? unknown.Please see serial number ((b)(4)), bead number (13), lot number (4793), device type (suture).What is the lot number of the linx device? 4793.Was there any pre-op motility testing for spasms? ph testing required per protocol (no motility).Site queried for additional information.

Event Description

It was reported that patient had intermittent esophageal spasms, with associated chest, and upper abdominal pain.Onset date: (b)(6) 2017; date of ae awareness: 07-feb-2018.Event characterization: esophageal spasms ae status/outcome: resolved.Date resolved: (b)(6) 2020; severity: moderate; is the event serious?: no.Office/clinical visit: checked date: (b)(6) 2020; dilation/pneumatic: checked date: (b)(6) 2020 other: checked explain: abdominal ultrasound: (b)(6) 2017.Comments: upon further review of medical records patient showed resolution of symptoms post dilation on (b)(6) 2020, at a non-study visit after study completion.

• Brand Name: 1.5T LINX, 13B
• 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: 10817811
• MDR Text Key: 215902878
• Report Number: 3008766073-2020-00167
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2020

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: 09/14/2017
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 4793
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2013
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention