FDA Adverse Event
Injury
Summary report: N
STRATA 2 VALVE, REGULAR
MDR report key: 3241666
·
Received July 22, 2013
Report
- Report Number
- 2021898-2013-00247
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- June 24, 2013
- Report Date
- June 24, 2013
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K042465
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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.
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 PATIENT UNDERWENT A VP SHUNT PROCEDURE FOR POST-SUBARACHNOIDAL HEMORRHAGE HYDROCEPHALUS. THE REPORT STATED THAT THE PRESSURE SETTING OF THE VALVE WAS CHANGED FROM 2.0 TO 0.5 DUE TO POOR FLOW OF CSF AFTER THE PROCEDURE. ACCORDING TO THE REPORT, CONTRAST STUDY OF THE SHUNT SHOWED NO ANOMALIES. REPORTEDLY, THE VALVE WAS EXPLANTED AND REPLACED WITH A HAKIM VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340387 | STRATA 2 VALVE, REGULAR | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | D36226 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | Hospitalization| R |