FDA Adverse Event
Injury
Summary report: N
SIPHONGUARD, CSF FLD CONTROL DV
MDR report key: 1352068
·
Received March 25, 2009
Report
- Report Number
- 1226348-2009-00073
- Event Type
- Injury
- Date Received
- March 25, 2009
- Date of Event
- February 19, 2009
- Manufacturer
- CODMAN & SHURTLEFF, INC/MEDOS S.A.
- Product Code
- JXG
- PMA / PMN Number
- K992173
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
AFFILIATE REPORTED THAT IN 2009, THE SIPHON GUARD AND COMPETITOR'S VALVE WERE IMPLANTED IN THE PATIENT POSSIBLY HAVING TUBERCULOUS MENINGITIS. AT ABOUT 12 DAYS LATER, UNDER DRAINAGE WAS NOTED. ABOUT 2 DAYS LATER, IT WAS CONFIRMED THROUGH CT THAT THE VENTRICLES OF THE PATIENT'S BRAIN BECAME LARGE. AT APPROX 10 DAYS, THE PRODUCTS WERE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIPHONGUARD, CSF FLD CONTROL DV | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC/MEDOS S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |