FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2063787
·
Received April 15, 2011
Report
- Report Number
- 1644487-2011-00820
- Event Type
- Injury
- Date Received
- April 15, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 18, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A CARDIOLOGIST THAT THE PATIENT WAS EXPERIENCING ASYSTOLIC EPISODES. THE PHYSICIAN IS NOT SURE IF IT IS RELATED TO THE VNS. PER THE PATIENT, THE VNS HAS BEN TURNED OFF FOR SOME TIME, BUT THE PHYSICIAN COULD NOT CONFIRM THIS AS HE IS NOT A VNS PHYSICIAN. THE PHYSICIAN IS NOT EXACTLY SURE WHEN SYMPTOMS FIRST BEGAN, BUT THEY HAVE RECENTLY BECOME WORSE. ATTEMPTS FOR FURTHER INFORMATION 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 | 011608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Life Threatening |