MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Model Number LXMC16

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

Patient Problems Dysphagia/ Odynophagia (1815); Nausea (1970); Pain (1994); Vomiting (2144); Numbness (2415)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).No lot number was provided therefore a device history could not be done.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 is the lot #? when is the explant date set? does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? will the device be returning for analysis?.

Event Description

It was reported that a female patient was implanted with lxmc16 (b)(6) 2021.Was dilated by gi (b)(6) 2021 after complaining of nausea and vomiting, patient continues to be symptomatic post dilation¿vague symptoms of pain, lower lip numbness, etc.Patient requests the device be removed.Tentative removal in (b)(6).

Manufacturer Narrative

(b)(4).Date sent: 11/11/2021.Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.Additional information was requested, and the following was obtained: what is the lot #? unk.When is the explant date set? yes, removed (b)(6) 2021.Does the patient have any of the allergies to metals? unk if so, what test have been done to test for metal allergies.Unk.Is the patient currently taking currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? psych issues per the surgeon, complained of chronic pain and difficulty with swallowing post linx, numbness, inconsistent symptoms.Was there any hiatal or crural repair done at the same time as the implant? yes.Was mesh used at time of implant? no.Will the device be returning for analysis? requested, checking.

• Brand Name: LINX 1.5 16 BEAD US
• 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: 12615075
• MDR Text Key: 275924903
• Report Number: 3008766073-2021-00203
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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 Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female