FDA Adverse Event
Other
Summary report: N
SOPHY ADJUSTABLE PRESSURE VALVE SHUNT
MDR report key: 479931
·
Received August 18, 2003
Report
- Report Number
- 3001587388-2003-00007
- Event Type
- Other
- Date Received
- August 18, 2003
- Report Date
- August 14, 2003
- Manufacturer
- SOPHYSA
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EXPLANTATION IN 2002 FOR A LOW DRAINAGE IN LOW PRESSURE. (MORE INFO WAS ASKED A FEW TIMES TO THE NEUROSURGEON WITHOUT SUCCESS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOPHY ADJUSTABLE PRESSURE VALVE SHUNT | SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS | JXG | SOPHYSA | * | L0199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |