FDA Adverse Event
Death
Summary report: N
CSF-SHUNT KIT, BURR HOLE VALVE, 12MM, MEDIUM, STANDARD
MDR report key: 2111663
·
Received May 25, 2011
Report
- Report Number
- 2021898-2011-00083
- Event Type
- Death
- Date Received
- May 25, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 21, 2011
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K831678
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. 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, AFTER THE VALVE WAS IMPLANTED, THERE WAS NO IMPROVEMENT IN THE PATIENT'S SYMPTOMS. ACCORDING TO THE REPORT, DURING THE REVISION SURGERY, FLUID WOULD NOT FLOW THROUGH THE PERITONEAL CATHETER UPON PUMPING THE VALVE, SO THE VALVE WAS EXPLANTED. THE PATIENT PASSED AWAY SOON AFTER THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CSF-SHUNT KIT, BURR HOLE VALVE, 12MM, MEDIUM, STANDARD | JXG | MEDTRONIC NEUROSURGERY | C70783 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| H| R |