MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-23 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[188064705]
(b)(4). Date sent: 03/23/2020. Abdominal distention device implanted. 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 are the next steps /management plan?
Patient Sequence No: 1, Text Type: N, H10
[188064706]
It was reported that the patient had an unknown linx device implanted on (b)(6) 2017, due to acid reflux. The patient initially had relief from gerd after implant but more recently has experienced bloating of his stomach and lots of phlegm with a cough. Then the patient continued to have acid reflux as well as coughing up phlegm, swollen, distended and tender stomach. The patient returned to his implant doctor to have the linx expanded and the doctor chose not to expand, indicating it looked fine. The patient continued to have the issues mentioned, returned to his implant doctor, had the linx was expanded but he continued to have the issues with acid reflux, phlegm, and swollen, distended and tender stomach. The patient returned to the implant doctor, requesting to have the device removed and the implant doctor wasn't responsive to the patient's request. No current plans have been made to have the linx explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00054 |
| MDR Report Key | 9864883 |
| Report Source | CONSUMER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-02 |
| Date of Event | 2017-06-12 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Catalog Number | UNK LINX MAGNETIC IMPLANT |
| Lot Number | 8101 |
| 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 | 2020-03-23 |