FDA Adverse Event
Malfunction
Summary report: N
CODMAN VIPV SYSTEM
MDR report key: 1918527
·
Received November 5, 2010
Report
- Report Number
- 1226348-2010-00362
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Manufacturer
- CODMAN & SHURTLEFF, INC. MEDOS S.A.
- Product Code
- JXG
- PMA / PMN Number
- K061876
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. ADD'L PMA/510(K)#: K050739.
Description of Event or Problem · 1
AFFILIATE REPORTED THAT SURGEON ATTEMPTED TO CHANGE THE PT'S SHUNT SETTING AND CONTINUOUSLY HAD A "REPEAT ADJUSTMENT" MESSAGE FROM THE MACHINE. WHEN THE MACHINE FINALLY READ ADJUSTMENT COMPLETE, SURGEON HAD THE PT X-RAYED TO CHECK THE SETTING AND THE PT'S SHUNT WAS SET AT THE LOWEST SETTING AND NOT AT THE SETTING THAT HE CHOSE. THE SURGEON WAS ABLE TO OBTAIN DESIRED PRESSURE SETTING BY USING AN OLDER PROGRAMMER. PT DID NOT UNDERGO A REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN VIPV SYSTEM | VALVE PROGRAMMER | JXG | CODMAN & SHURTLEFF, INC. MEDOS S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |