FDA Adverse Event
Other
Summary report: N
POLARIS ADJUSTABLE PRESSURE VALVE SHUNT
MDR report key: 725424
·
Received June 6, 2006
Report
- Report Number
- 3001587388-2006-00012
- Event Type
- Other
- Date Received
- June 6, 2006
- Date of Event
- March 15, 2006
- Report Date
- May 24, 2006
- Manufacturer
- SOPHYSA SA
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE VALVE HAS BEEN RETURNED ON 05/23/2006. ANALYSIS HAS TO BE DONE.
Description of Event or Problem · 1
THIS POLARIS ADJUSTABLE PRESSURE VALVE WAS IMPLANTED IN A PT APPROX IN 2005. IT WAS SET AT 70 MM H2O. AS THE NEUROSURGEON TRIED TO ADJUST THE PRESSURE OF THE VALVE IN VAIN, HE REPLACED THE VALVE A FEW DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLARIS ADJUSTABLE PRESSURE VALVE SHUNT | SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS | JXG | SOPHYSA SA | POLARIS (R) VALVE | P0339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |