FDA Adverse Event
Injury
Summary report: N
HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
MDR report key: 1111891
·
Received August 12, 2008
Report
- Report Number
- 1226348-2008-00215
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- July 5, 2008
- Manufacturer
- CODMAN & SHURTLEFF, INC./MEDOS S.A.
- Product Code
- JXG
- PMA / PMN Number
- K974739
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- 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 PATIENT WAS CLOSED, AND THEN BROUGHT BACK FOR ANOTHER SURGERY, BECAUSE THE SURGEON CHANGED PRESSURE TO ADJUST VALUE OF PROGRAMMABLE VALVE SEVERAL TIMES, AND THEY DID NOT GET CONTROL OF THE VENTRICLES SIZE. THE PATIENT SHOWED SYMPTOMS OF OVERDRAINAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC./MEDOS S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |