MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS13; ANTI-REFLUX IMPLANT

Model Number LS-[13]

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Itching Sensation (1943); Pain (1994); Hernia (2240)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2018.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history for lot 5149 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information: patient stated he had been "having problems" with device.He had the device explanted in atlanta and withdrew consent for participation.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: what symptoms did the patient present with that lead to the explant of the link? what was the explant date? is the link available for return?.

Event Description

It was reported that preoperative to linx implant procedure, on (b)(6) 2015, patient was diagnosed with gerd.Patient then had implantation of 13 linx lot #5149 with no complications.The linx device was implanted on (b)(6) 2015.Post-approval study patient-reported experiencing itching and burning in his chest and was diagnosed with bile reflux.The patient is being referred to a gastroenterologist for further evaluation.

Manufacturer Narrative

(b)(4).Date sent: 4/28/2021.D6b = unknown, assumed 1st day of month that the device was explanted.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.Additional information was requested, and the following was obtained: what symptoms did the patient present with that lead to the explant of the link? what was the explant date? is the link available for return? answer = patient states he was having epigastric pain and saw 2 different md's in atlanta who told him linx device was too tight and had caused a hernia.He had it removed and replaced with a larger size and has had no further problems.He doesn't recall md name or exact date.

• Brand Name: LS13
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11627330
• MDR Text Key: 256159517
• Report Number: 3008766073-2021-00070
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005028
• UDI-Public: 00855106005028
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2017
• Device Model Number: LS-[13]
• Device Catalogue Number: LS13
• Device Lot Number: 5149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 77