FDA Adverse Event
Malfunction
Summary report: N
STRATA 2, ADJUSTABLE VALVE, REGULAR
MDR report key: 1182688
·
Received September 25, 2008
Report
- Report Number
- 2021898-2008-00227
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 28, 2008
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K042465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
PRODUCT TESTED PRIOR TO SURGERY AND FOUND TO BE DEFECTIVE, AS IT DID NOT DRAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATA 2, ADJUSTABLE VALVE, REGULAR | 84JXG | JXG | MEDTRONIC NEUROSURGERY | NA | C23125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |