FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1083153
·
Received July 24, 2008
Report
- Report Number
- 1644487-2008-01667
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 26, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED BY THE TC THAT THE SERIAL ADAPTER CABLE WAS NOT MAKING A GOOD CONNECTION. THIS CABLE WAS ISOLATED AS THE PROBLEM COMPONENT WHEN ANOTHER SERIAL ADAPTER CABLE WAS USED WITH THE SYS WHICH MADE A GOOD CONNECTION AND RESOLVED THE ISSUE. A NEW SERIAL ADAPTER CABLE WAS SHIPPED TO THE TC. PROD HAS BEEN RETURNED TO THE MFR FOR PROD ANALYSIS. PROD ANALYSIS IS PENDING ON THIS COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |