FDA Adverse Event
Injury
Summary report: N
POLARIS ADJUSTABLE VALVE 30-200
MDR report key: 2816996
·
Received October 24, 2012
Report
- Report Number
- 3001587388-2012-00389
- Event Type
- Injury
- Date Received
- October 24, 2012
- Date of Event
- October 2, 2012
- Report Date
- October 24, 2012
- Manufacturer
- SOPHYSA
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
SPV WAS IMPLANTED IN (B)(6). THE INITIAL SETTING WAS 110 MMHG. HOWEVER, AS IT SEEMED TO BE DRAINED TOO MUCH, THE DOCTOR CHANGED THE PRESSURE SETTING TO 150. HE WAITED FOR THREE DAYS, BUT NO CHANGE WAS SEEN. THEREFORE, HE CHANGED IT TO 200 AND WAITED TWO OR THREE DAYS NO CHANGE. HE THEN REPLACED THE VALVE WITH A NEW SPV. HE WOULD LIKE SOPHYSA TO MEASURE EACH PRESSURE TO SEE IF THE MEASURED VALUES ARE WITHIN ITS SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLARIS ADJUSTABLE VALVE 30-200 | POLARIS ADJUSTABLE VALVE | JXG | SOPHYSA | POLARIS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |