FDA Adverse Event
Injury
Summary report: N
SIPHONGUARD, CSF FLD CONTROL DEVICE
MDR report key: 1015064
·
Received March 18, 2008
Report
- Report Number
- 1226348-2008-00061
- Event Type
- Injury
- Date Received
- March 18, 2008
- Date of Event
- February 14, 2008
- 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
CODMAN HAS REQUESTED TO HAVE THE DEVICE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
AFFILIATE REPORTED THAT THE DEVICE WAS IMPLANTED BECAUSE OVERDRAINAGE WAS NOTED AT 190MMH2O. BUT THE OVERDRAINAGE WAS NOTED EVEN AFTER THE IMPLANTATION AND ANOTHER VALVE (COMPETITOR'S) WAS ADDED. THE AFFILIATE ALSO EXPLAINED THAT THE OVER DRAINAGE DID NOT IMPROVE AFTER THE SG WAS IMPLANTED. THEREFORE, THE DOCTOR DOUBTED IF THE SG CORRECTLY CONTROLLED THE FLUID RATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIPHONGUARD, CSF FLD CONTROL DEVICE | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC./ MEDOS S.A. | NA | CHMBZ0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |