FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1096484
·
Received August 1, 2008
Report
- Report Number
- 1644487-2008-01764
- Event Type
- Injury
- Date Received
- August 1, 2008
- Date of Event
- July 3, 2008
- Report Date
- July 3, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PT WAS EXPERIENCING BRADYCARDIA. A CARDIOLOGIST REPORTED HER LOWEST PULSE RATE TO BE AT 45 AND HER AVERAGE RATE TO BE AT 56. THE PT HAS A PRE-EXISTING CONDITION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND IS ON ANTI-HYPERTENSIVE MEDICATIONS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |