FDA Adverse Event
Injury
Summary report: N
LINX REFLUX MANAGEMENT SYSTEM
MDR report key: 6012462
·
Received October 7, 2016
Report
- Report Number
- 3008766073-2016-00069
- Event Type
- Injury
- Date Received
- October 7, 2016
- Date of Event
- September 9, 2016
- Report Date
- September 9, 2016
- Manufacturer
- TORAX MEDICAL, INC.
- Product Code
- LEI
- PMA / PMN Number
- P100049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT HAD THE LINX DEVICE EXPLANTED FOR UNKNOWN REASONS. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. PATIENT HAD LINX DEVICE REMOVED ON (B)(6) 2016. MULTIPLE REQUESTS HAVE BEEN MADE TO THE CENTER FOR ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663481 | LINX REFLUX MANAGEMENT SYSTEM | ANTI-REFLUX IMPLANT | LEI | TORAX MEDICAL, INC. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| O |