MAUDE Adverse Event Report: 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 Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Paresis (1998); Vomiting (2144); Neck Pain (2433); Choking (2464)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: unknown; captured as awareness date exact implant date is unknown.Implanted in 2017.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.Additional information was requested, and the following was obtained: what is the management plan for the patient? what is the tens for? when was the gastroparesis diagnosed? was the gastroparesis diagnosed before or after the implant? have you ever had a gastric emptying study? answer = this is not an official complaint, so i do not want to spend a lot of time going back and forth on q&a at this point in time.I am scheduled to talk to the ucla surgeon who installed my lynx device later in the month.In terms of quick answers: gastroparesis diagnosed with emptying studies 2016/2017 prior to lynx installation.Lynx and hiatal hernia repair surgery and pylorplasty all done concurrently 2017 to address aspirations / reflux problems.Tens for upper-neck pain: traps, levator scap, rhomboids.Used to as adjunct to pt.Gastroparesis problem ¿ ongoing emptying problems re-validated during recent eye surgery (b)(6) 2021 ¿ wherein asthesiologist suctioned out over 130 ml of undigested food from stomach while under general anesthesia during a strabismus eye surgery - even after adhering to fasting orders the day before.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: what is the product code? what is the lot number of the device? when was the exact implant date? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a linx device - does not know model number, if the model is on recall list.The device was implanted in 2017 and 2 days after pills got stuck in the device and gi had to remove them, but since then has been fine.Patient states that when under stress, he eats too much and has some choking and throwing up.About 6 months ago chronic reflux returned and coughs nonstop through the night.Patient also has gastroparesis, and they found a lot of undigested food in intestines, so that could be some of the problem.2 months ago, patient began having trouble getting food down, but small sips of water resolved episode.Referred patient back to personal physician and he has arrangements made to have a full work up, including pulmonary reflux.He had the linx evaluated in 2019 and beads were intact.Patient states that the linx device was life changing and would like to get back to that status.Has upper neck pain and uses tens.

Manufacturer Narrative

(b)(4).Date sent: 10/28/2021.Additional information provided: good news for you all, i contacted my ucla surgeon.He explained that the lynx models recalled were only a small batch and that his office would have been notified if any of the devices he installed were defective.So, my lynx device by deduction is not part of the recall.So please stop with the questions.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• MDR Report Key: 12633384
• MDR Text Key: 281007227
• Report Number: 3008766073-2021-00207
• 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,Followup
• Report Date: 10/28/2021

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: 09/29/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 10/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention