MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-06 for LINX 1.5 16 BEAD US LXMC16 manufactured by Torax Medical, Inc..
[174857110]
(b)(4). The dhr for lot # 23859 was reviewed. No ncs, defects, or reworks related to the product complaint were found.
Patient Sequence No: 1, Text Type: N, H10
[174857111]
It was reported,? A linx device was implanted on (b)(6) 2019 and patient experienced recurrent hiatal hernia, chest pain, bloating, nausea pre-explant, confirmed by egd with dilation under fluro, ct scan. Patient has hypertension. The linx device was explanted on (b)(6) 2019 and converted to toupet.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00002 |
| MDR Report Key | 9553937 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-06 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2019-12-20 |
| Date Added to Maude | 2020-01-06 |
| 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 | LINX 1.5 16 BEAD US |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-01-06 |
| Catalog Number | LXMC16 |
| Lot Number | 23859 |
| 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 | 2020-01-06 |