FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2061982
·
Received April 6, 2011
Report
- Report Number
- 1644487-2011-00729
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- February 7, 2011
- Report Date
- March 9, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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
REPORTER INDICATED A PT HAD VNS LEAD AND GENERATOR REPLACEMENT SURGERY DUE TO A LEAD FRACTURE. THE EXPLANTED DEVICES HAVE BEEN RETURNED AND ARE CURRENTLY IN PRODUCT ANALYSIS. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 10904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |