FDA Adverse Event
Injury
Summary report: N
HAKIM INLINE PROGRAMMABLE VALVE SG
MDR report key: 654789
·
Received December 20, 2005
Report
- Report Number
- 1226348-2005-00298
- Event Type
- Injury
- Date Received
- December 20, 2005
- Date of Event
- November 23, 2005
- Manufacturer
- CODMAN & SHURTLEFF, INC/MEDOS S.A
- Product Code
- JXG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SALES REP REPORTS THAT DR EXPLANTED PRODUCT CODE 82-3162 BECAUSE HE SUSPECTS AN OCCLUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAKIM INLINE PROGRAMMABLE VALVE SG | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC/MEDOS S.A | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |