FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1993292
·
Received December 22, 2010
Report
- Report Number
- 1644487-2010-02877
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- November 22, 2010
- Report Date
- November 22, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: DEVICE FAILURE IS SUSPECTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S VNS SHOWED HIGH IMPEDANCE DURING A ROUTINE OFFICE VISIT AND HIS GENERATOR INDICATED THAT IT WAS NEARING END OF SERVICE. THE PT WAS ALSO NOTED AS HAVING AN INCREASE IN SEIZURES AND BEHAVIORAL CHANGES. A BATTERY LIFE CALCULATION ESTIMATED -0.3 YEARS UNTIL END OF SERVICE. DURING A REVIEW OF THE DIAGNOSTICS HISTORY, IT WAS FOUND THAT ON (B)(6) 2007 HIGH IMPEDANCE WAS FOUND BUT ON (B)(4) 2007 THE DIAGNOSTICS HAD RETURNED TO NORMAL. THIS COULD BE AN INDICATOR OF POSSIBLE POSITIONAL LEAD BREAK. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SURGERY TO REPLACE THE VNS LEAD AND GENERATOR IS LIKELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 1273 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention |