FDA Adverse Event
Injury
Summary report: N
HAKIM VALVE, RIGHT ANGLE RES, UNITIZED SG
MDR report key: 1212613
·
Received October 24, 2008
Report
- Report Number
- 1226348-2008-00283
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- September 30, 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
UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
AFFILIATE REPORTED THAT THE VENTRICLES OF THE PT'S BRAIN WERE TOO LARGE, THEREFORE, THE DOCTOR CHANGED THE PRESSURE LOWER. SINCE THE SITUATION DID NOT CHANGE AND THE VALVE NEEDED TO BE REPLACED. IT WAS IMPLANTED IN 2008 AND REPLACED AT ABOUT 25 DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAKIM VALVE, RIGHT ANGLE RES, UNITIZED SG | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC./MEDOS S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |