MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-06 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[185661640]
(b)(4). Date sent: (b)(6) 2020. (b)(4). The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed. The device remains implanted. Additional information received: do you have the linx product code, lot number and serial number (if applicable)? No sure, he does have his card saying he can't go into an mri. On what date was the device implanted in (b)(6) of 2016? Unknown. Were there any intra-operative complications during implant? Not to the patient? S knowledge. It worked fine for a year. He started to have reflux and didn't want to lay down. He found a linx surgeon in (b)(6) who wanted to take the device out and do a fundoplication. He was a snowbird at the time. Dr. (b)(6) said he was one of the first to have it done and it would of also fixed his hiatal hernia. Was there any hiatal or crural repair done at the same time as the implant? Hiatal hernia was done at a second surgery. He was the 72nd to ever have the linx device implanted. He had the hernia fixed and about two three years since he's had issues. He's had part of his lung removed. The reflux went down his trachea according to dr. T. He's starting to cough and has an irritated trachea. His most painful surgery was the lung removal. Have you had a follow-up appointment with the surgeon that implanted the linx device or another physician? (b)(6) he has an appoint with a linx surgeon in fl. 6) have you had any diagnostic testing done to address the symptoms that you have been experiencing? Yes, "all that". One of the most painful ones he had done when the tube was shoved down his throat. That was done prior to the implant. He also did an acid test. Additional information received: after the initial surgery of the implant of the lynx, which worked for about a year, my gerd returned. My surgeon then performed a hiatal hernia repair, which worked for about 4 years until the gerd returned. My surgeon in (b)(6), (b)(6). , performed an endoscopy and found the lynx has moved above the diaphragm. He also said he could see the lynx from inside the esophagus. He feels the lynx may be too tight and is eroding my esophagus. Very scary! He recommended replacing the current lynx with one that is not as tight or a nissen fundoplication. I am scheduled for a cat scan (b)(6) to be sure he knows what is going on before we proceed with a surgery. On (b)(6) 2020: spoke with the patient. On (b)(6) 2020 he had an endoscopy done. The doctor thinks that the linx is too tight and not allowing all the food to get through. The doctor also stated that there were no esophageal problems which the patient stated? Which was good.? He also stated that dr. (b)(6) thinks the linx has moved and has eroded into his esophagus. He had a test done which showed that he was only digesting half of the food and dr. (b)(6) started him on generic nexium as this caused in increase in the acid. The patient stated that he had a ct scan prior to the one on the (b)(6) but he guessed it did not show anything and he does not know the results of the ct scan that was done on (b)(6) 2020. The patient will follow-up with dr. (b)(6) and obtain medical records/images, results of ct scan and find out what the management plan will be. He will update us with any additional information obtained.
Patient Sequence No: 1, Text Type: N, H10
[185661641]
It was reported that the linx device implanted in april 2016 may be leaking because when he lies prone he gets mild gerd. Patient age: (b)(6) (male).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00043 |
| MDR Report Key | 9800642 |
| Report Source | CONSUMER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 4188 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN |
| Manufacturer Phone | 6107428552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK LINX MAGNETIC IMPLANT |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-03-06 |
| Catalog Number | UNK LINX MAGNETIC IMPLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAX MEDICAL, INC. |
| Manufacturer Address | 4188 LEXINGTON AVENUE NORTH SHOREVIEW MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |