FDA Adverse Event
Other
Summary report: N
CSF-FLOW CONTROL VALVE, CONTOURED REGULAR, MEDIUM
MDR report key: 490868
·
Received October 16, 2003
Report
- Report Number
- 2021898-2003-00151
- Event Type
- Other
- Date Received
- October 16, 2003
- Report Date
- September 18, 2003
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VALVE DID NOT PASS THE PREIMPLANTATION TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CSF-FLOW CONTROL VALVE, CONTOURED REGULAR, MEDIUM | CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | * | A31827 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |