FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1940660
·
Received December 22, 2010
Report
- Report Number
- 1644487-2010-02869
- Event Type
- Injury
- Date Received
- December 22, 2010
- Date of Event
- October 5, 2007
- Report Date
- November 30, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THROUGH A COMPANY REP THAT A VNS PT'S DEVICE WAS REMOVED PERIOPERATIVELY DUE TO INFECTION. THE SURGEON AT THE MOMENT IS CONSIDERING RE-IMPLANTING THE PT. F/U WAS MADE WITH THE PT'S TREATING NEUROLOGIST AT THE TIME OF INFECTION. THE NEUROLOGIST INDICATED THE CAUSE OF THE INFECTION WAS RELATED TO VNS SURGERY AS THE PT HAD UNCONTROLLED DIABETES MELLITUS. THE INFECTION WAS FOUND ON (B)(6) 2007 AROUND THE PULSE GENERATOR IN THE CHEST INCISION. THE PT'S GENERATOR WAS EXPLANTED ON (B)(6) 2007 AND THE RESULTS OF CULTURES WERE POSITIVE FOR (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |