FDA Adverse Event
Malfunction
Summary report: N
CODMAN VPV SYSTEM
MDR report key: 1172850
·
Received September 19, 2008
Report
- Report Number
- 1226348-2008-00242
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- 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 Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE EVALUATION VERIFIED THAT THE PROGRAMMER WAS FOUND FUNCTIONALLY. THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE VERIFIED. BASED ON THE RESULTS OF THIS INVESTIGATION, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.
Description of Event or Problem · 1
REP REPORTED THAT THE SURGEON PROGRAMMED A VALVE IN A PATIENT, AND HE RECEIVED AN "ADJUSTMENT COMPLETE" MESSAGE. UPON X-RAY OF THE PATIENT, THEY OBSERVED THAT THE VALVE NEVER CHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN VPV SYSTEM | VALVE PROGRAMMER | JXG | CODMAN & SHURTLEFF, INC/MEDOS S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |