FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1172594
·
Received September 19, 2008
Report
- Report Number
- 1644487-2008-02251
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- January 1, 2008
- Report Date
- August 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WOULD HAVE THEIR LEAD AND GENERATOR REPLACED IN 2008, DUE TO A LEAD BREAK. FOLLOW UP WITH THE PHYSICIAN'S OFFICE REVEALED THAT DIAGNOSTICS WERE PERFORMED THAT GAVE HIGH LEAD IMPEDANCE READINGS AND X-RAYS TAKEN CONFIRMED THE LEAD BREAK. THE PATIENT WAS ALSO EXPERIENCING A WORSENING SEIZURE PATTERN WHICH THE TREATING PHYSICIAN ATTRIBUTED TO THE LEAD BREAK. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AS WELL AS A COPY OF THE X-RAYS 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 | 009946 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |