FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1111875
·
Received August 12, 2008
Report
- Report Number
- 1644487-2008-01875
- Event Type
- Malfunction
- Date Received
- August 12, 2008
- Date of Event
- July 23, 2008
- Report Date
- July 23, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED A VNS WAND FAILED TO PROGRAM PTS. THE VNS WAND WAS RETURNED FOR PRODUCT ANALYSIS. ANALYSIS REVEALED THAT THE WAND SERIAL DATA CABLE, WHICH PRODUCED COMMUNICATION ERRORS, HAD AN OPEN CONDUCTOR. A KNOWN GOOD BENCH SERIAL DATA CABLE WAS SUBMITTED AND ALL COMMUNICATIONS ERRORS CLEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING WAND | PROGRAMMING WAND | LYJ | CYBERONICS, INC. | 201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |