FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1061982
·
Received June 13, 2008
Report
- Report Number
- 1644487-2008-01373
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- May 12, 2008
- Report Date
- May 15, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THE PATIENT WAS SCHEDULED FOR A VNS THERAPY SYSTEM REPLACEMENT SURGERY. THE REASON FOR THE SURGERY WAS NOT KNOWN AT THE TIME OF THE INITIAL REPORT. REVIEW OF THE PATIENT'S PROGRAMMING HISTORY REVEALED A HIGH IMPEDANCE ON DIAGNOSTIC TESTING. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 011863 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |