FDA Adverse Event
Malfunction
Summary report: N
STRATA 2, ADJUSTABLE VALVE, REGULAR
MDR report key: 1081936
·
Received July 23, 2008
Report
- Report Number
- 2021898-2008-00155
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- February 28, 2008
- Report Date
- June 23, 2008
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K042465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE VALVE WAS PATENT AND PASSED SIPHON AND REFLUX TESTING. THE VALVE WAS NOT WITHIN SPECIFICATIONS FOR ALL PRESSURE-FLOW AND PREIMPLANTATION TESTING. THE VALVE DID NOT PASS LEAK TESTING DUE TO A TEAR ON THE TOP OF THE RESERVOIR DOME. DEBRIS WITHIN THE VALVE MAY INTERFERE WITH THE VALVE MECHANISM RESULTING IN HIGH PRESSURE-FLOW RESULTS. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR PRODUCTS ARE 100% TESTED AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 1
IT REPORTED THAT THE VALVE WAS FAULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATA 2, ADJUSTABLE VALVE, REGULAR | 84JXG | JXG | MEDTRONIC NEUROSURGERY | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |