MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-04 for UNK LINX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..
[182230598]
(b)(4). Date sent: 03/04/2020. Only event year known: 2020. The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed. Additional information was requested, and the following was obtained: what was the implant date? What was the explant date? What is the lot number for the linx device? What is the product code for the linx device that was removed? Was ph testing performed prior to explant to confirm recurrent reflux? After implant, was the device initially effective in controlling reflux? When did the recurrent reflux begin? Response: no further information available.
Patient Sequence No: 1, Text Type: N, H10
[182230599]
It was reported that export/explantation of linx after sleeve and reflux symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00037 |
| MDR Report Key | 9788995 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-04 |
| 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 | 2020-03-04 |
| 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 | 2020-03-04 |