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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Scleroderma (2062); Obstruction/Occlusion (2422); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/20/2019.Date of event: unknown.The lot was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

Title: robotic assisted removal of magnetic esophageal sphincter with fundoplication authors: meara m.P., alexander c., rodman c., renton d.B., schwartz j citation: surg endosc (2018); 32:s50¿s66.Doi: http://dx.Doi.Org/10.1007/s00464-018-6120-5.Magnetic esophageal sphincter augmentation is a relatively new technique for management for reflux beyond traditional medications.The long-term outcomes of this device and concerns for potential failure or erosion remain a paramount issue as the device is applied to an increasing number of individuals, both in the united states and worldwide.This case involves a (b)(6)-year-old female patient with a past surgical history significant for linx device (ethicon) implantation in 2013.The patient noted that since the surgery, she had no relief of the reflux and that in fact, the reflux had worsened to a point where the symptoms were lifestyle limiting.The device was removed from the patient intact.A standard nissen fundoplication was performed with minimal impact on the procedure from the previously removed device.In conclusion, robotic assisted removal of magnetic esophageal sphincter with fundoplication can be completed safely and effectively.Robotic removal and repeat fundoplication can be considered in patient's whose device has subsequently failed and removal is necessary.

Manufacturer Narrative

(b)(4).Date sent: 09/26/2019.H10: corrected data: patient codes scleroderma and obstruction filed in error.They have been removed.

• 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: 9097720
• MDR Text Key: 162814445
• Report Number: 3008766073-2019-00465
• 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,Followup
• Report Date: 08/27/2019

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 09/26/2019
• 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