FDA Adverse Event
Malfunction
Summary report: N
STRATA ADJUSTABLE VALVE
MDR report key: 1023802
·
Received April 2, 2008
Report
- Report Number
- 2021898-2008-00081
- Event Type
- Malfunction
- Date Received
- April 2, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 5, 2008
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO THE MFR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VALVE PRESSURE LEVEL COULD NOT BE ADJUSTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATA ADJUSTABLE VALVE | JXG | MEDTRONIC NEUROSURGERY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |