FDA Adverse Event
Malfunction
Summary report: N
DELTA VALVE, REGULAR, PERFORMANCE LEVEL 2
MDR report key: 2298495
·
Received October 7, 2011
Report
- Report Number
- 2021898-2011-00245
- Event Type
- Malfunction
- Date Received
- October 7, 2011
- Date of Event
- September 9, 2011
- Report Date
- September 9, 2011
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K902783
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MEDTRONIC NEUROSURGERY HAS NOT RECEIVED A RESPONSE TO REQUESTS FOR MORE INFO REGARDING THE ALLEGED MALFUNCTION OF THE DEVICE. THE VALVE WAS PATENT. IT PASSED SIPHON AND LEAK TESTING. HOWEVER, THE DEVICE DID NOT MEET REQUIREMENTS FOR REFLUX TESTING, PRESSURE-FLOW TESTING, OR PREIMPLANTATION PRESSURE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. IT IS UNK WHAT CAUSED THE REPORTED EVENT. NO IMPACT TO THE PT WAS REPORTED. 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 DURING THE SURGERY, THE VALVE ALLEGEDLY "WOULD NOT STAY PRIMED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA VALVE, REGULAR, PERFORMANCE LEVEL 2 | JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | A95583 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |