FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1031402
·
Received April 18, 2008
Report
- Report Number
- 1644487-2008-00939
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- January 1, 2007
- Report Date
- April 10, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT GENERATOR REVISION SURGERY WAS PERFORMED DUE TO PT GROWTH. ADDITIONALLY, IT WAS NOTED THAT THE GENERATOR HAD REACHED END OF SERVICE. THE PRODUCT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. PRODUCT ANALYSIS REVEALED THAT A COMPONENT WAS OUT OF SPECIFICATION ON THE GENERATOR THAT MAY HAVE CONTRIBUTED TO PREMATURE END OF SERVICE. THE COMPONENT OUT OF SPECIFICATION WAS R35, A SELECTABLE VALUE RESISTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |