FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1007370
·
Received February 29, 2008
Report
- Report Number
- 1644487-2008-00440
- Event Type
- Injury
- Date Received
- February 29, 2008
- Date of Event
- February 23, 2007
- Report Date
- September 24, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LEE, YOUNG. JAE. "LATERAL THIRD INFRACLAVICULAR IMPLANTATION OF THE VAGAL NERVE STIMULATION GENERATOR THROUGH AXILLARY INCISION." JOURNAL KOREAN NEUROSURGERY, SOC 42 (2007): 16-19.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT'S GENERATOR HAD MIGRATED MORE THAN 2 CM FROM THE INITIAL IMPLANT POSITION. IT WAS IMPLIED THAT SURGERY OCCURRED BY "ANCHORING THE GENERATOR TO THE SUBCUTANEOUS INFRACLAVICULAR POCKET PROPERLY AND BY DISSECTING THE SUBCUTANEOUS POCKET TO SMALL DIMENSION, AS NEEDED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | NONE | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |