FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1063627
·
Received June 20, 2008
Report
- Report Number
- 1644487-2008-01426
- Event Type
- Malfunction
- Date Received
- June 20, 2008
- Date of Event
- May 16, 2008
- Report Date
- May 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO MANUFACTURER THAT THE VNS PATIENT WAS HAVING SURGERY TO REPLACE THE GENERATOR DUE TO AN UNKNOWN REASON. THE GENERATOR WAS RETURNED TO MANUFACTURER FOR ANALYSIS AND THE RETURN PRODUCT FORM STATED THAT THE REASON FOR THE PRODUCT RETURN WAS DUE TO A "MALFUNCTION". ONLY THE GENERATOR WAS REPLACED DURING THE SURGERY. ANALYSIS OF THE RETURNED GENERATOR IS UNDERWAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN ARE ALSO UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 016488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |