FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1193200
·
Received October 7, 2008
Report
- Report Number
- 1644487-2008-02437
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- August 6, 2008
- Report Date
- September 17, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED TO A MFR CONSULTANT THAT THE PHYSICIAN HAD A PROGRAMMING WAND THAT WAS NOT "WORKING". THE WAND WAS RETURNED FOR PRODUCT ANALYSIS. THE SERIAL DATA CABLE, WHICH PRODUCED COMMUNICATION ERRORS, HAD AN INTERMITTENT CONDUCTOR. A KNOWN GOOD BENCH SERIAL DATA CABLE WAS SUBSTITUTED AND ALL COMMUNICATIONS ERRORS CLEARED. AFTER THE SERIAL DATA CABLE WAS SUBSTITUTED, THE PROGRAMMING WAND WAS ELECTRICALLY TESTED AND WAS OPERATING WITHIN THE DESIGNED LIMITS OF THE FINAL ELECTRICAL TEST REQUIREMENTS.
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 |