FDA Adverse Event
Injury
Summary report: N
BIPOL LEAD MODEL 302
MDR report key: 905654
·
Received September 2, 2007
Report
- Report Number
- 1644487-2007-01387
- Event Type
- Injury
- Date Received
- September 2, 2007
- Date of Event
- November 1, 2006
- Report Date
- August 2, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
X-RAYS REVIEWED BY MFR. MFR REVIEW OF X-RAYS SHOWED ELECTRODE PLACEMENT AT C2 TO C3.
Description of Event or Problem · 1
REPORTER INDICATED THAT A PT WAS UNDERGOING REVISION SURGERY TO CORRECT THE ORIGINAL PLACEMENT OF HIS VNS THERAPY LEAD, AS IT WAS TOO HIGH AND WAS CAUSING HIS NECK MUSCLES TO TWITCH WITH STIMULATION. MFR REVIEW OF X-RAYS SHOWED ELECTRODE PLACEMENT AT C2 TO C3. EXPLANTED LEAD WAS RETURNED TO MFR FOR PRODUCT ANALYSIS, HOWEVER, THAT ANALYSIS IS NOT YET COMPLETE. GOOD FAITH ATTEMPTS FOR FURTHER INFO ARE CURRENTLY BEING MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 1300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization |