FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2083049
·
Received May 5, 2011
Report
- Report Number
- 1644487-2011-01009
- Event Type
- Injury
- Date Received
- May 5, 2011
- Date of Event
- January 1, 2011
- Report Date
- April 5, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS EXPLANTED TODAY AS SHE NEVER REALLY RECEIVED MUCH BENEFIT FROM VNS AND SHE CLAIMED THE GENERATOR WAS UNCOMFORTABLE. THE SURGEON REMOVED THE SYSTEM AND SAID THAT THE GENERATOR WAS IN THE AXILLARY AREA AND HE COULD SEE WHERE IT WOULD BE UNCOMFORTABLE WHEN LYING ON HER SIDE. IT WAS ALSO NOTED THAT THE COILS WERE PLACED UPSIDE DOWN ON THE NERVE WITH THE ANCHOR TETHER PROXIMAL TO HEAD. 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 | 010763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |