FDA Adverse Event
Injury
Summary report: N
STRATA VALVE/SHUNT
MDR report key: 2111710
·
Received May 25, 2011
Report
- Report Number
- 2021898-2011-00106
- Event Type
- Injury
- Date Received
- May 25, 2011
- Date of Event
- February 24, 2011
- Report Date
- April 18, 2011
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AN (B)(6) PT HAD A SHUNT REVISION. ACCORDING TO THE REPORT, THE STRATA SHUNT WAS NOT DRAINING PROPERLY. THE VALVE WAS EXPLANTED AND REPLACED WITH A CONTOUR VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRATA VALVE/SHUNT | JXG | MEDTRONIC NEUROSURGERY | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |