FDA Adverse Event
Malfunction
Summary report: N
DELTA SHUNT KIT, SMALL PERFORMANCE LEVEL 1.5
MDR report key: 1182677
·
Received September 25, 2008
Report
- Report Number
- 2021898-2008-00228
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 26, 2008
- Report Date
- August 26, 2008
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K902783
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN RETURNED TO MFR.
Description of Event or Problem · 1
VALVE DOES NOT WORK PROPERLY. SHUNT REPLACED WITH NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA SHUNT KIT, SMALL PERFORMANCE LEVEL 1.5 | 87JXG | JXG | MEDTRONIC NEUROSURGERY | NA | A99133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |