FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1202927
·
Received October 17, 2008
Report
- Report Number
- 1644487-2008-02485
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- January 1, 2007
- Report Date
- September 24, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED INITIALLY THAT A VNS PT WAS EXPERIENCING PAINFUL STIMULATION AND THAT A DECREASE IN THE PT'S PULSE WIDTH, ENACTED FOR PT COMFORT, HAD RESOLVED THE ISSUE. DIAGNOSTICS PERFORMED AT THE PT'S LAST VISIT CONFIRMED PROPER DEVICE FUNCTION. THE RPTR ALSO INDICATED THAT THE DECREASE IN PULSE WIDTH HAD RESULTED IN OCCASIONAL BREAKTHROUGH SEIZURES EXPERIENCED BY THE PT PROMPTING THE RPTR TO DISABLE THE PT'S DEVICE SO THAT SHE COULD BE ADMITTED INTO ANOTHER MEDICAL DEVICE STUDY TRIAL. GOOD FAITH ATTEMPTS FOR ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 7310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |