FDA Adverse Event
Injury
Summary report: N
STD PV W/ PRECHAMBER, HIGH
MDR report key: 677811
·
Received February 21, 2006
Report
- Report Number
- 1226348-2006-00017
- Event Type
- Injury
- Date Received
- February 21, 2006
- Date of Event
- January 24, 2006
- Manufacturer
- CODMAN & SHURTLEFF, INC/MEDOS S.A.
- Product Code
- JXG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE AFFILIATE REPORTS THAT THE PATIENT WAS SYMPTOMATIC, SUFFERING FROM HEADACHES. THE SURGEON REMOVED THE VALVE BECAUSE HE SUSPECTED A BLOCKAGE. THE PATIENT IS IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STD PV W/ PRECHAMBER, HIGH | CENTRAL NERVOUS SYSTEM & COMPONENTS | JXG | CODMAN & SHURTLEFF, INC/MEDOS S.A. | NA | 1010103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |