FDA Adverse Event
Injury
Summary report: N
POLARIS SPV ADJUSTABLE VALVE
MDR report key: 4301329
·
Received October 27, 2014
Report
- Report Number
- 3001587388-2014-00370
- Event Type
- Injury
- Date Received
- October 27, 2014
- Date of Event
- August 19, 2014
- Report Date
- October 21, 2014
- Manufacturer
- SOPHYSA
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE WON'T BE RETURNED FOR EVAL. THIS IS A REPORTED CASE FOR SOPHYSA'S INFO ONLY.
Description of Event or Problem · 1
ON (B)(6), THE SURGEON TRIED TO LOWER THE PRESSURE SETTING FROM 70 TO 30MMHG UNDER X-RAY BUT IT WAS NOT POSSIBLE. CHANGE TO 110, 150, AND 200 WAS POSSIBLE. THE VALVE WAS EXTRACTED ON (B)(6) TO FIND SOME DEPOSITS IN THE VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683066 | POLARIS SPV ADJUSTABLE VALVE | POLARIS ADJUSTABLE VALVE | JXG | SOPHYSA | POLARIS | Y0422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |