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 Cardiac Arrest (1762); Muscle Spasm(s) (1966); Nausea (1970); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: (b)(6) 2020.Date of event: unknown.Device remains implanted.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported, (b)(6) old daughter had a linx implant on an unknown date and eight weeks, post op, the daughter is eating six small meals a day and still having little 'heart attacks', esophageal spasms, as well as severe nausea and vomiting.The surgeon will not do any further imaging, testing, radiation or dilation.The surgeon told the mother that the device needs to be removed and the mother indicated that the daughter can't live without it.The daughter has been hospitalized and steroids given but no progress noted, and steroids are due to be tapered starting tomorrow.

• 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 ; 6107428552
• MDR Report Key: 9799345
• MDR Text Key: 185659371
• Report Number: 3008766073-2020-00039
• 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: consumer
• Type of Report: Initial
• Report Date: 02/11/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/06/2020
• 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): Hospitalization