MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2005-12-30 for POLARIS ADJUSTABLE PRESSURE VALVE SHUNT POLARIS (R) VALVE SPV-400 manufactured by Sophysa.
[36264218]
The valve has been returned in (b)(4) 2005. Analysis has to be done. See sanned page.
Patient Sequence No: 1, Text Type: N, H10
[36264219]
This polaris adjustable pressure valve was implanted to a pt in (b)(6). The implantation depth was less than 10 mm from the skin. In early (b)(6), the neurosurgeon attempted to decrease the setting pressure of the valve to 330 mmh2o ( or 230 mmh2o) with an adjustment magnet and a pressure selector, in vain. He replaced the valve with another spv-400 in (b)(6). He succeeded in changing the pressure of the explanted valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001587388-2005-00384 |
| MDR Report Key | 5345165 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2005-12-30 |
| Date of Report | 2005-12-30 |
| Date of Event | 2005-12-09 |
| Date Mfgr Received | 2005-12-23 |
| Date Added to Maude | 2016-01-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEAN-CHRISTOPHE AUDRAS |
| Manufacturer Street | 22 RUE JEAN ROSTAND PARC CLUB ORSAY UNIVERSITE |
| Manufacturer City | ORSAY, CEDEX F-91893 |
| Manufacturer Country | FR |
| Manufacturer Postal | F-91893 |
| Manufacturer Phone | 69353500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POLARIS ADJUSTABLE PRESSURE VALVE SHUNT |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS |
| Product Code | GYK |
| Date Received | 2005-12-30 |
| Returned To Mfg | 2005-12-26 |
| Model Number | POLARIS (R) VALVE |
| Catalog Number | SPV-400 |
| Lot Number | P0322 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOPHYSA |
| Manufacturer Address | 22 RUE JEAN ROSTAND PARC CLUB ORSAY UNIVERSITE ORSAY, CEDEX F-91893 FR F-91893 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-12-30 |