D
Patient 1
VALVE FAILED TO REPROGRAM AND WAS REPLACED.
MAUDE MDR 254142
- MDR report key
- 254142
- Report number
- 1219655-1999-00205
- Event key
- 0
- Event type
- 3
- Date received
- 1999-12-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MATTHEW KING
- Address
- 325 PARAMOUNT DR RAYNHAM MA 02767 US
- Phone
- 508-508-5080
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER | CNS SHUNT | JOHNSON & JOHNSON PROFESSIONAL, INC. | JXG | NA | 82-3110 | PG8605 | K974739 | Y | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1999-12-15 | 0 |