FDA Adverse Event
Other
Summary report: N
SOPHY ADJUSTABLE PRESSURE VALVE SHUNT
MDR report key: 493953
·
Received October 24, 2003
Report
- Report Number
- 3001587388-2003-00020
- Event Type
- Other
- Date Received
- October 24, 2003
- Date of Event
- September 30, 2003
- Report Date
- October 23, 2003
- Manufacturer
- SOPHYSA
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
BEFORE IMPLANTATION, THE NEUROSURGEON LIKES TO PERFORM THE CLOSURE PRESSURE OF HIS VALVES. FIRST, AS THE BULLHOLE RESERVOIR WAS NOT NECESSARY, HE DISCONNECTED IT BY FORCE. THEN USING A MANOMETER, HE FILLS VALVE WITH A SYRINGE OF STERILE WATER. HE READ THE PRESSURE WHEN THE VALVE WAS CLOSING. USING THE VALVE ADJUSTED IN MEDIUM PRESSURE, HE DIDN'T FIND IT MET HIS SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOPHY ADJUSTABLE PRESSURE VALVE SHUNT | SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS | JXG | SOPHYSA | * | M0365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |