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

Patient Problems Diarrhea (1811); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Nerve Damage (1979); Pain (1994); Paresis (1998); Ulcer (2274); Abdominal Distention (2601)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).No lot number was provided therefore a device history could not be done.Additional information received: received message this week from patient who indicated the device was explanted on (b)(6) 2020 at frisco medical center by steve duffy, md.He indicated that dr.Duffy¿s office was given permission to share information with us related to the explant.Patient has authorized permission for us to analyze the device and review his medical records.

Event Description

The patient underwent hiatal hernia repair and linx placement on (b)(6) 2019.The patient began having issues with severe bloating post-op and surgeon set up a gastric emptying study that allegedly indicated a diagnosis of gastroparesis from the (b)(6) 2019 surgery.The patient¿s health continues to decline and surgeon ¿admitted fault¿ to the patient that the vagus nerve was damaged intra-operatively on (b)(6) 2019.

Manufacturer Narrative

(b)(4) date sent: 9/23/2021 h6: gastrointestinal system (e10) additional information received: information from received explant op notes: preop diagnoses: dysphagia, pain, postprandial diarrhea and profound gastrocolic reflex.Mild cameron ulceration on the underside of the cardia of the stomach and otherwise normal egd with mild esophagitis grade a.

Manufacturer Narrative

(b)(4).Date sent: 1/7/2022.Investigation summary: as the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.

• 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 55126 ; 6107428552
• MDR Report Key: 12422355
• MDR Text Key: 271491897
• Report Number: 3008766073-2021-00180
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2022

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: 08/18/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/09/2021; 01/07/2022
• Supplement Dates FDA Received: 09/23/2021; 01/07/2022
• 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: 48 YR
• Patient Sex: Male