MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-12 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[179311969]
Pc (b)(4). Date sent: 02/12/2002. Unknown, assumed 1st day of month that complaint was reported. The lot was not provided; therefore, the manufacturing record evaluation could not be performed. Additional information: hiatal hernia repaired at the same time of implant. Was taking prescription pepcid. Is no longer taking medication. Unknown dosage. Diagnostic testing includes: (b)(6) 2018, chest xrays, (b)(6) 2018, xray of esophagus, marshmallow study with barium, problems eating and swallowing since placement. Marshmallow, stopped at the ge junction, where the linx was located, took more barium and passed the marshmallow through. (b)(6) 2018, another barium marshmallow test, procedure started with just a barium swallow, no marshmallow and there was a delay of the barium in the region of the distal esophagus. Eventually cleared but intermittent tertiary contractions noted. Then did barium marshmallow swallow, following the barium only test and delay of transit of the marshmallow at the midesophagial level. Do you have your linx product code, lot number and serial number (if applicable)? 13 bead, do not have specific information. On what date was the device implanted in (b)(6) of 2017? (b)(6) 2017. Were there any intra-operative complications during implant? No. Have you had a follow-up appointment with the surgeon that implanted the linx device or another physician? There was follow-up within a couple of weeks of implant. One of the gi studies indicated there were 13 beads on the linx device but only five of the beads moved, but it took 82 seconds with the barium to move down. Had a bravo study last (b)(6) 2019, a four-day study, and on the first couple days of the study there was very low amounts of acid, 5%-6% of the day but on the third day, the acid levels went up to 76% of the day, so it was determined the device fell off the linx band and was sitting in the stomach for days three and four. Then decided, due to the low amounts on the first day, the patient doesn? T have acid reflux. After seeing the initial implant doctor, was referred to the gi doctor, gi doctor ordered the barium studies, gi doctor stretched the esophagus because she was having a lot of problems swallowing, and couldn? T swallow food, ending in vomiting the food, so doctor stretched it but it didn? T make a whole lot of difference, time went by and was referred to a different doctor that had more experience with the linx, because the first gi doctor didn? T have any experience with the linx, and was afraid that if he stretched the linx too far, he would break it. So implant doctor sent patient to an experienced linx doctor, who stretched the linx but she still continued to have problems eating. Decided to give it time but kept getting burning and pain sensation, is telling doctor that she is refluxing but doctor says she isn? T refluxing because she has the linx band. So patient is inquiring why she is having this burning in her esophagus and throat that she didn? T have, even before the band? Doctor response was that they didn? T know. Meanwhile, having tons of lung issues, bronchitis, inflammation of lungs, like every month, saw a pulmonologist, running tests, and through ct scans, finding that the problem with her airways and lungs is that she is aspirating acid into her lungs and into her stomach. Gi doctor not listening. Developing horrible pain in breast bone, between breasts, where the linx band would be. Gi doctor says its not linx band but muscular but the issue has been going on for a couple of months. Saw pulmonologist at (b)(6) hospital in (b)(6), she ordered ct scans and scans are showing the top of the stomach is coming through the linx band and into the esophagus, which is why the patient is having the chest pain. Gi doctor doesn? T believe the results and sends patient to (b)(6) hospital in (b)(6) to see their top esophageal doctor in (b)(6). Saw specialist on (b)(6) 2020, did another esophagram and scope, attached a 96 hour bravo study, to detect reflux, won? T get results until (b)(6) 2020. Initial suggestion from specialist that the linx should be removed and have a fundoplication surgery or gastric bypass, current specialist is dr (b)(6) not convinced reflux is the issue. The doctor that performed the implant on the patient, she was his first linx implant case. Dr (b)(6) was the implant doctor and dr. (b)(6) is the current linx specialist.
Patient Sequence No: 1, Text Type: N, H10
[179311970]
It was reported that the linx device was implanted (b)(6) of 2017 for acid reflux. The caller indicated the reflux never went away after the linx device was implanted. The caller indicated her doctors would like to explant the device and pursue other surgical options. No other information is known at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00024 |
| MDR Report Key | 9703028 |
| Report Source | CONSUMER |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-03 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-12 |
| 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 | 2020-02-12 |
| 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 | 2020-02-12 |