FDA Adverse Event
Malfunction
Summary report: N
DELTA VALVE
MDR report key: 192567
·
Received October 7, 1998
Report
- Report Number
- 2021898-1998-00113
- Event Type
- Malfunction
- Date Received
- October 7, 1998
- Report Date
- September 8, 1998
- Manufacturer
- MEDTRONIC PS MEDICAL
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
WHEN DR EXPLANTED DELTA VALVES (FOR REASON OTHER THAN VALVE PROBLEM), HE DISCOVERED A LEAK IN THE DELTA CHAMBER. IT WAS LATER DISCOVERED THAT THE LEAKAGE WAS DUE TO HIS EXPLANTATION TECHNIQUE. (MFR. REPORT #2021898-1998-00112-00114).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA VALVE Implant | CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS | JXG | MEDTRONIC PS MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |