FDA Adverse Event
Other
Summary report: N
HAKIM INLINE PROGRAMMABLE VALVE SG
MDR report key: 817700
·
Received January 31, 2007
Report
- Report Number
- 817700
- Event Type
- Other
- Date Received
- January 31, 2007
- Date of Event
- December 22, 2006
- Manufacturer
- CODMAN & SHURTLEFF, INC/MEDOS S.A.
- Product Code
- JXG
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE PT REC'D A VALVE IN 2004. PATIENT WAS SYMPTOMATIC WITH HEADACHES. PRESSURE OF VALVE WAS CHANGED AND IT WAS REPORTED THAT THE PT WAS RESPONSIVE TO THE PRESSURE CHANGE AT TIMES AND NOT AT OTHER TIMES. THE DECISION WAS THEN MADE TO REPLACE THE VALVE. THE DR MENTIONED THAT HE FELT IT HAD TO DO WITH THE POSTURE OF THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAKIM INLINE PROGRAMMABLE VALVE SG | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC/MEDOS S.A. | NA | PAN628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |