FDA Adverse Event
Injury
Summary report: N
UNKNOWN STRATA NSC VALVE/SHUNT
MDR report key: 1490994
·
Received October 2, 2009
Report
- Report Number
- 2021898-2009-00195
- Event Type
- Injury
- Date Received
- October 2, 2009
- Date of Event
- October 31, 2007
- Report Date
- September 4, 2009
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED EVENT WAS IDENTIFIED DURING THE COURSE OF A RETROSPECTIVE CLINICAL STUDY (CONDUCTED UNDER IRB) INVOLVING A REVIEW OF PT CASE RECORDS AND DATA ANALYSIS. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBERS WERE AVAILABLE. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFR.
Description of Event or Problem · 1
CHIARI TYPE I MALFORMATION DEVELOPED POST SHUNT CREATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN STRATA NSC VALVE/SHUNT | 84JXG | JXG | MEDTRONIC NEUROSURGERY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |