FDA Adverse Event
Malfunction
Summary report: N
STRATA 2, ADJUSTABLE VALVE, REGULAR
MDR report key: 1153169
·
Received September 4, 2008
Report
- Report Number
- 2021898-2008-00212
- Event Type
- Malfunction
- Date Received
- September 4, 2008
- Date of Event
- June 25, 2008
- Report Date
- August 12, 2008
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K042465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HIT IN THE HEAD WITH A FOOTBALL AND THAT THE VALVE THEN CEASED TO FUNCTION PROPERLY. AFTER THE INCIDENT, THE PATIENT'S HEAD BEGAN TO SWELL AND THE VALVE WAS EXPLANTED. AFTER REVISION, THE DOCTOR NOTED A PROBLEM WITH THE DELTA CHAMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATA 2, ADJUSTABLE VALVE, REGULAR | 84JXG | JXG | MEDTRONIC NEUROSURGERY | NA | A93947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |