FDA Adverse Event
Other
Summary report: N
CSF-UNITIZED SHUNT KIT, REGULAR, MEDIUM PRESSURE
MDR report key: 483460
·
Received September 9, 2003
Report
- Report Number
- 2021898-2003-00127
- Event Type
- Other
- Date Received
- September 9, 2003
- Date of Event
- August 7, 2003
- Report Date
- August 13, 2003
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTRICULAR SEGMENT BROKE OFF AT 2 CM FROM THE END WHEN THE PHYSICIAN TRIED TO SLIDE THE RIGHT ANGLE CLIP AT SETUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CSF-UNITIZED SHUNT KIT, REGULAR, MEDIUM PRESSURE | CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | * | Y9946 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |