FDA Adverse Event
Injury
Summary report: N
POLARIS SPV ADJUST. VALVE/BURR HOLE RESERVOIR
MDR report key: 3670366
·
Received February 26, 2014
Report
- Report Number
- 3001587388-2013-00444
- Event Type
- Injury
- Date Received
- February 26, 2014
- Date of Event
- December 19, 2013
- Report Date
- February 13, 2014
- Manufacturer
- SOPHYSA SA
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT HAS BEEN REPORTED TO THE MANUFACTURER ON (B)(4) 2013; RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
SPVB WAS IMPLANTED ON (B)(6). ITS SETTING WAS AT THE HIGH POSITION BUT THE PT SUFFERED FROM OVERDRAINAGE. THEREFORE, THE SYSTEM WAS EXTRACTED ON (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117437 | POLARIS SPV ADJUST. VALVE/BURR HOLE RESERVOIR | VALVE ADJUSTABLE WITH RESERVOIR | JXG | SOPHYSA SA | POLARIS VALVE ADJUST | A0023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |