FDA Adverse Event
Injury
Summary report: N
PROGRAMMABLE VALVE SYSTEM SPECIAL DEVICE
MDR report key: 751167
·
Received August 14, 2006
Report
- Report Number
- 1226348-2006-00223
- Event Type
- Injury
- Date Received
- August 14, 2006
- Date of Event
- July 20, 2006
- Manufacturer
- CODMAN & SHURTLEFF, INC./MEDOS S.A.
- Product Code
- JXG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CODMAN HAS REC'D THE DEVICE FOR EVAL. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
SALES REP REPORTED THAT THE VALVE FRACTURED AT THE POINT WHERE THE PROGRAMMING PORTION IS AFFIXED TO THE SIPHON DEVICE. THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED (ALSO USED ALONG WITH THE VALVE WAS 82-1707 & 82-1695. THERE WERE NO COMPLAINTS WITH THESE DEVICES).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMABLE VALVE SYSTEM SPECIAL DEVICE | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC./MEDOS S.A. | NA | DY211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | 82-1695| 82-1707 |