FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2241434
·
Received August 18, 2011
Report
- Report Number
- 1644487-2011-01903
- Event Type
- Malfunction
- Date Received
- August 18, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 21, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED BY A NEUROLOGIST THAT A VNS PATIENT'S LEAD WAS FRACTURED AND WAS CONFIRMED ON X-RAY IMAGES. THE IMAGES HOWEVER, WERE NOT RETURN TO MANUFACTURER FOR REVIEW. PATIENT HAD A REPLACEMENT SURGERY ON (B)(6) 2011 WHERE BOTH LEAD AND GENERATOR WERE REPLACED. GOOD FAITH ATTEMPTS TO OBTAIN MORE INFORMATION REGARDING PATIENT'S FRACTURED LEAD AND TO OBTAIN THE PRODUCTS BACK FOR ANALYSES WILL BE MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 2185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |