FDA Adverse Event
Malfunction
Summary report: N
POLARIS ADJUSTABLE VALVE 30-200 WITH ANTECHAMBER
MDR report key: 2219041
·
Received August 4, 2011
Report
- Report Number
- 3001587388-2011-00246
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- July 21, 2011
- Report Date
- August 4, 2011
- Manufacturer
- SOPHYSA
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT IS THE SAME AS MFR REPORT# 3001587388-2011-244. AS REPORTED IN MFR REPORT# 3001587388-2011-244, THE FIRST VALVE WAS IMPLANTED ON (B)(6) BUT EXTRACTED ON (B)(6), DUE TO OCCLUSION. HOWEVER, THE NEW VALVE GOT OCCLUDED AGAIN. THE DR CHECKED THE FLOW UNDER X-RAY AND FOUND IT WAS NOT GOING INTO THE DISTAL CATHETER. IT WAS REPLACED WITH A NEW SPVA ON (B)(6). THE DR IS FURIOUS BECAUSE OF THESE TWO CONSECUTIVE INCIDENTS. HE WOULD LIKE TO KNOW IF THE VALVE IS DEFECTIVE. PLEASE INVESTIGATE AS SOON AS POSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLARIS ADJUSTABLE VALVE 30-200 WITH ANTECHAMBER | HYDROCEPHALUS VALVE | JXG | SOPHYSA | POLARIS VALVE | X0305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |