FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1822572
·
Received August 27, 2010
Report
- Report Number
- 1644487-2010-01966
- Event Type
- Injury
- Date Received
- August 27, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 28, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS EXPERIENCING A SUDDEN INCREASE IN SEIZURE ACTIVITY. NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, TRAUMA, OR OTHER EXTERNAL FACTORS PRECEDED THE ONSET OF THE EVENT. THE PHYSICIAN THINKS THE BATTERY IS DEPLETING ALTHOUGH ERI=NO. PT HAS BEEN REFERRED FOR GENERATOR REPLACEMENT SURGERY, BUT IT HAS NOT OCCURRED TO DATE. ATTEMPTS FOR FURTHER 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 | 200677 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |