FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1081549
·
Received July 25, 2008
Report
- Report Number
- 1644487-2008-01701
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- January 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
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT PHYSICIAN'S WAND WAS HAVING PROBLEMS COMMUNICATING WITH THE HANDHELD. A NEW PROGRAMMING WAND WAS RECEIVED AND COMMUNICATION ISSUES HAVE RESOLVED. PRODUCT ANALYSIS WAS PERFORMED ON THE PROGRAMMING WAND. THE SERIAL DATA CABLE, WHICH PRODUCED COMMUNICATION ERRORS, HAD AN INTERMITTENT CONDUCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING WAND | LYJ | CYBERONICS, INC. | 201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |