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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Syncope/Fainting (4411)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot number has not been provided.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.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.

Event Description

It was reported via journal article: swallow-induced syncope after magnetic sphincter augmentation: a case report and physiologic explanation.Author: mathew r.Smith1 · shahin ayazi1 · andrew d.Grubic1 · xinxin shen1 · blair a.Jobe1 citation: clinical journal of gastroenterology https://doi.Org/10.1007/s12328-021-01448-w.This study aimed to present a case of swallow induced syncope following magnetic sphincter augmentation (msa).A (b)(6)-year-old male who was found to have a 2 cm hiatal hernia and no evidence of esophagitis on egd and videoesophagram showed a 2 cm sliding hiatal hernia.During the preoperative counseling, different surgical options were discussed with the patient and he elected to undergo laparoscopic repair of hiatal hernia with insertion of a magnetic sphincter augmentation device.The procedure was performed without complication.A device with 14 magnetic beads (linx) was placed around the gastroesophageal junction while ensuring that the posterior vagus nerve was dissected away from the esophagus and placed outside the device in the standard fashion.He was discharged home when he was tolerating his diet and was instructed to eat at least one tablespoon of soft foods every hour while awake.On postoperative day 10, he contacted our clinic stating he had an episode of syncope.He admitted to this episode of syncope following eating and while seated where he described tunnel vision and then syncope for several seconds.Upon the first episode, he was seen in the clinic and evaluated.At that time, the patient appeared hemodynamically stable and he was referred to cardiology for cardiac work-up, which did not take place before having another episode of syncope and being admitted into the hospital.Upon the second swallow induced syncope episode, on postoperative day 33, where he fell and hit his head, it was determined that the magnetic sphincter device is the potential explanation for syncope episodes.Reported complications included swallow induced syncope episode.The patient then had the linx device removed laparoscopically.The patient recovered well from this surgery and at 5 months after the removal of the device had no further episodes of syncope.In conclusion, this dysautonomic syndrome is the result of vagal stimulation and in our patient, was likely triggered by esophageal dilation or local irritation of the vagus nerve from the expansion of the device during a food bolus.Two episodes of syncope after food bolus occurred with the device in place and upon removal of the device, the patient had no further episodes of syncope.Although this is an extremely rare complication of magnetic sphincter augmentation, it is one that physicians should be cognizant of given the dangers of syncopal events.

• 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: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN 55126 ; 6107428552
• MDR Report Key: 12042482
• MDR Text Key: 257522874
• Report Number: 3008766073-2021-00121
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2021

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR