FDA Adverse Event
Malfunction
Summary report: N
STRATA II VALVE, REGULAR
MDR report key: 3200469
·
Received July 1, 2013
Report
- Report Number
- 2021898-2013-00220
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 3, 2013
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K042465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS FOUND TO HAVE MALFUNCTIONED PRIOR TO IMPLANTATION WHEN THE PHYSICIAN CHECKED IT WITH A MANOMETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299263 | STRATA II VALVE, REGULAR | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | D11691 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |