FDA Adverse Event
Injury
Summary report: N
VNS THERAPY PULSE
MDR report key: 566962
·
Received January 21, 2005
Report
- Report Number
- 1644487-2005-00073
- Event Type
- Injury
- Date Received
- January 21, 2005
- Date of Event
- October 25, 2004
- Report Date
- December 22, 2004
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE PT HAD BEEN HOSPITALIZED DUE TO SHORTNESS OF BREATH. IT WAS REPORTED THAT THE PT HAS BEEN EXPERIENCING SHORTNESS OF BREATH SINCE VNS IMPLANT AND THE SHORTNESS OF BREATH WAS CONSTANT. NEUROLOGIST INDICATED THAT THE PT IS DOING BETTER WITH BRONCHODILATORS AND THAT THE SHORTNESS OF BREATH MAY POSSIBLY BE DUE TO DEVICE STIMULATION OR IMPLANT SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VNS THERAPY PULSE | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 102 | 8735 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| L| R | CURRENT MEDICATIONS INCLUDE: ZOLOFT-100 MG,QD| MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE 07/2005| DEPAKOTE 0 250MG, NO0N, TOPMAX-25MG,BID| DATE OF MFG 07/2006, STELIZATION LOT NO 8773| DEPAKOTE ER-500 MG, BID |