MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Vomiting (2144); Hernia (2240); Anxiety (2328); Syncope/Fainting (4411); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that a linx device was implanted on (b)(6) 2018.Since then the patient has suffered from chronic, violent coughing spasms, leading to concerns for retinal damage.The patient also suffers from retching (vomiting), dry heaving, esophageal and abdominal muscle spasms, syncope, temporarily lose consciousness (fainting), cracked ribs from violent spasms, torn abdominal muscles, muscle tears, developed a pronounced umbilical hernia, anxiety, infection, malaise, inflammation, esophagitis and gastritis and convulsing.The coughing and retching began in 2018 and lasted for most of the year.The patient continues to cough and retch and has lasted 32 months or 57% of the time since surgery.Patient was 57 years old at the time of implant.The cough started immediately after the device was implanted, the patient stayed in the hospital for 2 weeks with iv prednisone 24/7 before the spasms stopped.During the implant the old nissen wrap was taken down and the surgeon repaired the diagram and hiatal hernia.The patient is still waiting for approval from the insurance company to have linx removed.

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2022.No lot number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: what is the product code of the linx device? what is the lot number of the linx device? do we have permission to reach out to dr.(b)(6) to ask the below questions? if yes, do you have an email address for him? please let us know if and when the device is ever explanted.I would love for you to have the information you seek and "yes" you have my permission to seek it.Consider this a hipaa release! dr.(b)(6), who of course performed my implant has also recommended the explant in my case.(b)(6) who handles his appeals for him is located in his office, and available at phone number, (b)(6) or (b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 12/8/2022.Investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.Additional information received: the patient has not been seen by dr.Tieu since march 12, 2021.There is no documentation of the device being broken.The product code and lot number are unknown.The statement from mso dr.Soberman (the symptoms reported by the patient are unusual and numerous.There has been a report of swallow induced syncope that occurred after linx implantation and resolved after device removal.The inference is that the placement of the device caused irritation/stimulation of the vagus nerve that triggered the syncope.The reported symptoms in your patient could potentially be related to the vagus nerve.Here is a link to the case report referenced above.) along with the publication link (https://pubmed.Ncbi.Nlm.Nih.Gov/34053004/) was declined by the facility due to the patient not being seen in over a year and a half.The facility did not want to speak any further about this information.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 15845602
• MDR Text Key: 304135305
• Report Number: 3008766073-2022-00232
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/08/2022
• 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 Age: 57 YR
• Patient Sex: Male