FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1993852
·
Received February 11, 2011
Report
- Report Number
- 1644487-2011-00256
- Event Type
- Injury
- Date Received
- February 11, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 12, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A TREATING NURSE THAT A VNS PT EXPERIENCED AN INCREASE IN SEIZURE DURATION AND WAS SUSPECTING THE DEVICE TO BE NEAR END OF SERVICE. A BATTERY LIFE CALCULATION WAS PERFORMED AND INDICATED THE PT HAD 0.67 YEARS UNTIL ERI=YES. ADDITIONAL INFO WAS RECEIVED THROUGH A CLINIC NOTE DATED (B)(6) 2011 INDICATING THE PATIENT'S VNS BATTERY WAS DEAD. ADDITIONALLY, THE PT CONTINUED TO HAVE UP TO 12 SEIZURES PER DAY, OFTEN AS CLUSTERS. THE PT WAS TO BE REFERRED FOR PROPHYLACTIC VNS GENERATOR REPLACEMENT. FURTHER INFO WAS RECEIVED THROUGH AN IMPLANT CARD INDICATING THE PT UNDERWENT PROPHYLACTIC GENERATOR REPLACEMENT SURGERY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO AS WELL AS PRODUCT RETURNED 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 | 013382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention |