FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL
MDR report key: 1143663
·
Received August 28, 2008
Report
- Report Number
- 1644487-2008-02053
- Event Type
- Injury
- Date Received
- August 28, 2008
- Date of Event
- January 1, 1998
- Report Date
- July 29, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REFERENCE ARTICLE: LUNDGREN J, EKBERG O, OLSSON R. ASPIRATION: A POTENTIAL COMPLICATION TO VAGUS NERVE STIMULATION. EPILEPSIA 1998;39 (SEPTEMBER):998-1000.
Description of Event or Problem · 1
IT WAS REPORTED IN A ARTICLE THAT TWO CHILDREN SHOWED AN INCREASED DEGREE OF ASPIRATION DURING CONTINUOUS VNS STIMULATION EVALUATED BY VIDEORADIOGRAPHY DURING BARIUM SWALLOW. BOTH CHILDREN WITH THE INCREASED DEGREE OF ASPIRATION HAD SEVERE MENTAL RETARDATION AND MOTOR RETARDATION AND WERE DEPENDANT ON ASSISTED FEEDING. BOTH CHILDREN SHOWING THE INCREASED ASPIRATION HAVE A SEVERE MENTAL AND MOTOR IMPAIRMENT. REFERENCE MDR NUMBER: 1644487-2008-02052 FOR THE OTHER CHILD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |