FDA Adverse Event
Injury
Summary report: N
HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
MDR report key: 2000781
·
Received February 16, 2011
Report
- Report Number
- 1226348-2011-00059
- Event Type
- Injury
- Date Received
- February 16, 2011
- Manufacturer
- CODMAN & SHURTLEFF, INC, MEDOS S.A.
- Product Code
- JXG
- PMA / PMN Number
- K974739
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFO IS NOT AVAILABLE FOR EVAL. WITHOUT THE DEVICE AND/OR LOT INFO IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFO DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.
Description of Event or Problem · 1
AFFILIATE REPORTED THAT THE VALVE COULD NOT BE PROGRAMMED. THE DEVICE HAS NOT BEEN EXPLANTED AND THE PT IS BEING MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC, MEDOS S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |