FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1052244
·
Received May 23, 2008
Report
- Report Number
- 1644487-2008-01210
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- April 18, 2008
- Report Date
- April 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
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
REPORTER INDICATED THAT A VNS WAND FAILED TO PROGRAM A PT AT AN OFFICE VISIT. THE PT HAD PREVIOUSLY BEEN ABLE TO BE INTERROGATED EARLIER AT THE SAME VISIT, BUT THE REPORTER WAS NOW RECEIVING COMMUNICATION ERRORS. A VNS SYSTEMS DIAGNOSTICS TEST DONE EARLIER AT THE SAME VISIT WAS NORMAL. THE VNS WAND, COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ARE CURRENTLY IN PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING WAND | MUZ | CYBERONICS, INC. | 201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |