FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1358066
·
Received March 3, 2009
Report
- Report Number
- 1644487-2009-00389
- Event Type
- Malfunction
- Date Received
- March 3, 2009
- Date of Event
- April 30, 2001
- Report Date
- February 13, 2009
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ARTICLE CITATION: HOPPE, CHRISTIAN, CHRIS HELMSTAEDTER, PH.D, JUDITH SCHERRMANN, MD, AND CHRISTIAN E. ELGER, MD. "SELF-REPORTED MOOD CHANGES FOLLOWING 6 MONTHS OF VAGUS NERVE STIMULATION IN EPILEPSY PATIENTS." EPILEPSY & BEHAVIOR 2 (2001): 335-42.
Description of Event or Problem · 1
THE AUTHOR OF A SCIENTIFIC ARTICLE INDICATED THAT A VNS PATIENT EXPERIENCED AN INCREASE IN SEIZURES ABOVE THE PRE-VNS BASELINE. THE CAUSE OF THESE SEIZURES AND THEIR RELATIONSHIP TO VNS THERAPY IS UNKNOWN. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |