MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-13 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[179310594]
Pc (b)(4). Date sent: 02/13/2020. 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. X-ray image, lot number of the linx device.
Patient Sequence No: 1, Text Type: N, H10
[179310595]
It was reported that a linx was implanted on (b)(6) 2019. Since the surgery, has had indigestion, nausea, small amounts of food - cannot bend forward or exercise without extreme nausea. The caller went to the doctor and had an edg last tuesday. The doctor indicated the linx had separated in two places and the doctor said that he fixed one of them and wants to try again for the other one. Caller says that she has since learned that her initial diagnosis of heartburn was a misdiagnosis and is scheduled for an explant on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00029 |
| MDR Report Key | 9707384 |
| Report Source | CONSUMER |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-02-13 |
| 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 | 2020-02-13 |
| 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 | 2020-02-13 |