FDA Adverse Event
Other
Summary report: N
SOPHY ADJUSTABLE PRESSURE VALVE SHUNT
MDR report key: 519314
·
Received April 2, 2004
Report
- Report Number
- 3001587388-2004-00004
- Event Type
- Other
- Date Received
- April 2, 2004
- Report Date
- April 2, 2004
- 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
IMPLANTATION OF A SOPHYSA SHUNT FOR HYDROCEPHALUS TREATMENT IN 2003. TWO WEEKS LATER, PATIENT GOT FEVER AND 2 MONTHS LATER, A REVISION WAS OPERATED. INFECTION WAS LOCALIZED ON THE PERITONEAL CATHETER AND CONFIRMED BY THE HOSPTIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOPHY ADJUSTABLE PRESSURE VALVE SHUNT | SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS | JXG | SOPHYSA SA | * | N0195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | BO19-10 VENTRICULAR CATHETER.| SM8B SOPHY ADJUSTABLE PRESSURE VALVE |