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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.The lot was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported via journal article: title: magnetic sphincter augmentation is safe and effective for the long-term treatment of gastroesophageal reflux disease (gerd).Author/s: ganz r.A., bonavina l., demeester t.R., dunn d.H., lipham j.C., saino g., bona d., fockens p., bemelman w.Citation: gastroenterology (2009); 136 (5 suppl.1) :a739.Doi: http://dx.Doi.Org/10.1016/s0016-5085%2809%2963410-7.The authors previously demonstrated that the laparoscopic placement of a magnetic bioprosthesis (linx reflux management system; ethicon) at the gastroesophageal junction (gej), provides safe and effective gerd therapy on a short-term basis.The authors now extend those observations to 12 month follow-up.To date 44 patients (mean age 42.8) have been implanted with a median follow-up of 380 days (range 40-629 days).The linx device (ethicon) is a bracelet of titanium beads, with magnetic cores, laparoscopically placed around the gastro-esophageal junction (gej) in the region of the z-line.Reported complications included persistent dysphagia (n-1) in which the device was removed, and chest discomfort (n-1) which resolved completely at 55 days.In conclusion, sphincter augmentation using the linx device (ethicon) appears to be a safe, and effective, minimally-invasive, long-term gerd therapy, based on a small cohort.The treatment does not appear to produce long-term side effects typical of nissen fundoplication.The procedure is also reversible and preserves normal physiologic function.

• 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: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 9078419
• MDR Text Key: 161092833
• Report Number: 3008766073-2019-00454
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2019

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: 08/23/2019
• Initial Date FDA Received: 09/17/2019
• 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