FDA Adverse Event
Other
Summary report: N
CSF-SHUNT KIT, BURR HOLE VALVE, 16MM, MEDIUM
MDR report key: 483465
·
Received September 9, 2003
Report
- Report Number
- 2021898-2003-00128
- Event Type
- Other
- Date Received
- September 9, 2003
- Date of Event
- April 22, 2003
- Report Date
- August 11, 2003
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING PRIOR TO SURGERY, THE PRODUCT DID NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CSF-SHUNT KIT, BURR HOLE VALVE, 16MM, MEDIUM | CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | * | A20394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |