MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-01-21 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[175699250]
(b)(4). Maude report # mw5091745. 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.
Patient Sequence No: 1, Text Type: N, H10
[175699251]
It was reported, "in (b)(6) of 2016 a linx device manufactured by torax medical was implanted to treat gerd at (b)(6) and while in (b)(6), after other attempts to treat gerd such as ppi's had failed. While working in (b)(6) in (b)(6) of 2019, i noticed my gerd symptoms had returned. On (b)(6), i received a positive diagnosis through a test at university of (b)(6) at (b)(6) that the linx had failed and info that my device was part of a recall. Torax medical had agreed to pay for a replacement device but not the surgery or other costs associated with the operation. Because of this, i postponed the surgery for several months and attempted to manage my gerd symptoms with modifications to my diet and ppi's. On (b)(6), 2019 i scheduled the surgery to have the linx removed and have a fundoplication at the university of (b)(6) health center in (b)(6). At this time, my insurance company is denying paying for the surgery. Torax medical is also denying paying for the surgery. When the linx device was removed. It was examined by the dr and he commented the device had deteriorated similar to a cheap piece of jewelry and was broken. This indicated inferior quality of material and poor mfg oversight in the construction of the linx, which resulted in premature failure. Even though the device is under recall. Torax medical does not appear to be responsible for anything other than a replacement device. This does not seem morally or ethically right for a company to be allowed to take this approach. Also, i am faced with who will pay for the device removal, and fundoplication surgery, since my insurance company and torax medical are currently in denial to pay. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00015 |
| MDR Report Key | 9611333 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-01-21 |
| 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 | 2020-01-21 |
| Catalog Number | UNK LINX MAGNETIC IMPLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-21 |