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); Nausea (1970); Pain (1994); Swelling (2091)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown, assumed 1st day of month that complaint was reported.Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.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.Request for operative report.

Event Description

It was reported that about a week after his implant he has had numb tingling that started in his left arm.Around (b)(6) the tingling has moved in to both of his arms and now his hands are numb.Patient also experienced swelling in his arms and legs which has gone down but his fingertips feel like they have so much pressure in them that they are going to ¿blow¿.Seen cardiologist with no issue found.Seen a neurologist with suspicion of carpel tunnel, checked his spine and neck and no pinched nerves were found.Seen a rheumatologist which ran a cvc and metabolic panel which show his white blood cells way off the chart his absolute lymphocytes are 4892 and his absolute monocytes are 1692.Infection, leukemia, ms or lupus have been mentioned but none have not been confirmed yet.Still waiting to return to the rheumatologist in three weeks.Has an appointment with his implant surgeon on (b)(6) 2019.Patient mentioned that he¿s not sleeping due to the pain, he can¿t be near air conditioning because the cool air causes pain, loss of appetite, nauseous, weight gain.Patient also mention that getting food to go down gets stuck quite often and at times feels like he is suffocating, and he doesn¿t know what to do.Patient has been given pain medication but is afraid to take them.Patient did not state that his implant is causing any of these issues but is trying to rule it out.Patient is grateful for the relief his device has given him from his acid reflux.Patient stated that he does have a nickel allergy.Patient is unaware of what size his implant is or what the lot number is.Patient also stated that he has been to the er and they tell him they can¿t help him because of his implant.

• 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: 8336228
• MDR Text Key: 136064893
• Report Number: 3008766073-2019-00276
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/13/2019
• 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