FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 2161853
·
Received July 8, 2011
Report
- Report Number
- 1644487-2011-01529
- Event Type
- Injury
- Date Received
- July 8, 2011
- Date of Event
- October 1, 2010
- Report Date
- June 9, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES, ABOVE BASELINE PER THE PATIENT. PATIENT HAD REPORTED THAT IN OCTOBER THAT HER GENERATOR WAS AT END OF SERVICE AND REQUESTED THE NAMES OF SURGEONS THAT WOULD PERFORM GENERATOR REPLACEMENT. IT IS UNKNOWN IF THE INCREASE IN SEIZURES ARE RELATED TO THE GENERATOR BEING AT END OF SERVICE. CURRENTLY, SURGERY HAS NOT TAKEN PLACE. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102R | LYJ | CYBERONICS, INC. | 102R | 011066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Required Intervention |