FDA Adverse Event
Injury
Summary report: N
LINX REFLUX MANAGEMENT SYSTEM
MDR report key: 3843663
·
Received May 28, 2014
Report
- Report Number
- 3008766073-2014-00010
- Event Type
- Injury
- Date Received
- May 28, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 1, 2014
- Manufacturer
- TORAX MEDICAL INC.
- Product Code
- LEI
- PMA / PMN Number
- 100049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE UTILIZING THE LINX DEVICE, A PATIENT EXPERIENCED ONGOING GERD SYMPTOMS LEADING TO LINX DEVICE EXPLANT. ANTI-REFLEX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED ON (B)(6) 2012. GERD SYMPTOMS WERE ALLEVIATED POST LINX IMPLANT, YET SYMPTOMS RETURNED (B)(6) 2013. REPORTED THAT PATIENT DIAGNOSED WITH BARRETT'S ESOPHAGUS AT TIME OF EXPLANT. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2014. DEVICE FOUND IN THE CORRECT POSITION AND GEOMETRY. NISSEN FUNDOPLICATION INCLUDING HIATUS REPAIR PERFORMED AT TIME OF LINX EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314730 | LINX REFLUX MANAGEMENT SYSTEM | LEI | TORAX MEDICAL INC. | LS13 | 3499 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| S | HIATAL HERNIA REPAIR |