FDA Adverse Event
Other
Summary report: N
POLARIS (R) ADJUSTABLE PRESSURE VALVE SHUNT
MDR report key: 641410
·
Received October 13, 2005
Report
- Report Number
- 3001587388-2005-00026
- Event Type
- Other
- Date Received
- October 13, 2005
- Date of Event
- August 30, 2005
- Report Date
- October 13, 2005
- Manufacturer
- SOPHYSA SA
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS POLARIS ADJUSTABLE PRESSURE VALVE SPV WAS IMPLANTED TO A PATIENT WITH A PRESSURE ADJUSTED TO 30MM H20. SINCE THE PATIENT PRESENTED SHRINKING OF VENTRICLES, THE DOCTOR CHANGED THE PRESSURE OF THE SPV TO 70MMH20 ON JULY 6 AND RAISED IT GRADUALLY TO 200MMH20. THEN, HE REVISED THE VALVE WITH SM8 ON SEPTEMBER 1.
Description of Event or Problem · 1
THIS POLARIS ADJUSTABLE PRESSURE VALVE SPV WAS IMPLANTED TO A PT WITH A PRESSURE ADJUSTED TO 30 MMH2O. SINCE THE PT PRESENTED SHRINKING OF VENTRICLES, THE DR CHANGED THE PRESSURE OF THE SPV TO 70 MMH2O AND RAISED IT GRADUALLY TO 200 MMH2O. THEN, HE REVISED THE VALVE WITH SM8 IN 2005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLARIS (R) ADJUSTABLE PRESSURE VALVE SHUNT | SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS | JXG | SOPHYSA SA | POLARIS (R) VALVE | P0384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |