FDA Adverse Event
Malfunction
Summary report: N
STRATA II, ADJUSTABLE DELTA VALVE, SMALL
MDR report key: 1724272
·
Received June 4, 2010
Report
- Report Number
- 2021898-2010-00111
- Event Type
- Malfunction
- Date Received
- June 4, 2010
- Date of Event
- May 7, 2010
- Report Date
- May 7, 2010
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K042465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A LEAK IN THE VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATA II, ADJUSTABLE DELTA VALVE, SMALL | JXG | MEDTRONIC NEUROSURGERY | NA | C25666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |