MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2003-12-09 for SOPHY ADJUSTABLE PRESSURE VALVE SHUNT * SM8 manufactured by Sophysa Sa.
[21705504]
2003, a sophysa shunt was implanted to a patient. The sophysa shunt was composed of one sophy adjustable pressure valve (cat. #sm8), one ventricular catheter (cat. #pl06), and one peritoneal catheter (cat. #b905s). Some troubles appear for the patient with fever and vomiting. The revision was operated and analysis showed infection with pseudomonas aeruginosa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001587388-2003-00025 |
| MDR Report Key | 501934 |
| Report Source | 01,07 |
| Date Received | 2003-12-09 |
| Date of Report | 2003-12-09 |
| Date of Event | 2003-07-05 |
| Date Mfgr Received | 2003-09-17 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2003-12-22 |
| 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 | 0 |
| Manufacturer Contact | MR. JEAN-CHRISTOPHE AUDRAS |
| Manufacturer Street | 22, RUE J. ROSTAND PARC CLUB ORSAY UNIVERSITE |
| Manufacturer City | ORSAY CEDEX F-91893 |
| Manufacturer Country | FR |
| Manufacturer Postal | F-91893 |
| Manufacturer Phone | 69353500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOPHY ADJUSTABLE PRESSURE VALVE SHUNT |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS |
| Product Code | JQG |
| Date Received | 2003-12-09 |
| Returned To Mfg | 2003-09-17 |
| Model Number | * |
| Catalog Number | SM8 |
| Lot Number | N0022 |
| ID Number | * |
| Device Expiration Date | 2008-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 490723 |
| Manufacturer | SOPHYSA SA |
| Manufacturer Address | 22 RUE JEAN ROSTAND PARC CLUB ORSAY UNIVERSITE ORSAY, CEDEX FR F-91893 |
| Baseline Brand Name | SOPHY(R) ADJUSTABLE PRESSURE VALVE |
| Baseline Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS |
| Baseline Model No | * |
| Baseline Catalog No | SM8 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-09 |