FDA Adverse Event
Injury
Summary report: N
POLARIS ADJUSTABLE VALVE, 10-140
MDR report key: 1822044
·
Received August 19, 2010
Report
- Report Number
- 3001587388-2010-00241
- Event Type
- Injury
- Date Received
- August 19, 2010
- Date of Event
- July 30, 2010
- Report Date
- August 19, 2010
- Manufacturer
- SOPHYSA
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT HAS BEEN REPORTED TO MFR ON 07/30/2010. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A F/U REPORT.
Description of Event or Problem · 1
SINCE THE INITIAL PRESSURE SETTING WAS 80, THE DOCTOR CHANGED THE SETTING TO 110 AND THEN 140 BUT THE SITUATION DID NOT GET BETTER. THEREFORE, THE DOCTOR REPLACED THE VALVE WITH SPV-300 ON (B)(6) 2010. THE DOCTOR HAS BEEN USING POLARIS MANY TIMES, BUT NEVER EXPERIENCED SUCH A CASE. HE WOULD LIKE TO KNOW IF THE VALVE IS FAULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLARIS ADJUSTABLE VALVE, 10-140 | HYDROCEPHALUS VALVE | JXG | SOPHYSA | POLARIS VALVE | W0197 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |