FDA Adverse Event
Malfunction
Summary report: N
OSV II ONE PIECE SYSTEM WITH ANTECHAMBER 13CM CA
MDR report key: 694183
·
Received March 29, 2006
Report
- Report Number
- 9612007-2006-00009
- Event Type
- Malfunction
- Date Received
- March 29, 2006
- Report Date
- March 29, 2006
- Manufacturer
- INTEGRA NEUROSCIENCES IMPLANTS S.A.
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ONE SURGEON IMPLANTED THE DEVICE AND THE PATIENT EXPERIENCED A HIGH FEVER WITHIN 12 HRS. THE PATIENT BECAME VERY ILL. CSF CULTURES WERE TAKEN AND NO BACTERIAL INFECTION WAS FOUND. STEROIDS WERE GIVEN. THE SHUNT IS STILL IN THE PATIENT. A TUNNELER 990-010 WAS ALSO USED. MDR9612007-2006-00010 WAS FILED FOR THE TUNNELER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSV II ONE PIECE SYSTEM WITH ANTECHAMBER 13CM CA | OSV II | JXG | INTEGRA NEUROSCIENCES IMPLANTS S.A. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |