FDA Adverse Event
Malfunction
Summary report: N
DELTA VALVE, REGULAR, PERFORMANCE LEVEL 1
MDR report key: 2211061
·
Received August 5, 2011
Report
- Report Number
- 2021898-2011-00179
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 1, 2011
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K902783
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF THE VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS LEAKING PRIOR TO IMPLANTATION. ACCORDING TO THE REPORT, THE PT EXPERIENCED A DELAY IN SURGERY WHILE ANOTHER VALVE WAS FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA VALVE, REGULAR, PERFORMANCE LEVEL 1 | JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | C73648 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |