FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 1231133
·
Received November 12, 2008
Report
- Report Number
- 2021898-2008-00256
- Event Type
- Malfunction
- Date Received
- November 12, 2008
- Date of Event
- March 3, 2008
- Report Date
- October 14, 2008
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THE DEVICE HAS NOT BEEN RETURNED TO MFR.
Description of Event or Problem · 1
VALVE WAS OBSTRUCTED; ONLY LASTED 48 HR IN PT BEFORE IT HAD TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | JXG | MEDTRONIC NEUROSURGERY | A88074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |