FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2152416
·
Received June 22, 2011
Report
- Report Number
- 1644487-2011-01387
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 23, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PT HAD UNDERGONE A REVISION SURGERY DUE TO A LEAD FRACTURE. THE LEAD AND GENERATOR WERE EXPLANTED AND REPLACED. THE EXPLANTED PRODUCTS WERE RETURNED TO THE MFR FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS ON THE GENERATOR HAS BEEN COMPLETED. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECS. NO ANOMALIES WERE NOTED. SYSTEM DIAGNOSTICS ARE AVAILABLE FROM (B)(6) 2011. AT THAT TIME, THE DC/DC WAS 6 AND LEAD IMPEDANCE WAS HIGH. ATTEMPTS FOR ADD'L INFO FROM THE NEUROLOGIST AND SURGEON HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 6736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Female |