FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 2191311
·
Received July 27, 2011
Report
- Report Number
- 1644487-2011-01695
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 27, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S VNS INDICATED HIGHT IMPEDANCE DURING PRE-OPERATION DIAGNOSTICS. THE PT WAS TO HAVE BATTERY REPLACEMENT DUE TO END OF SERVICE, BUT THE SURGEON OPTED TO REPLACE THE VNS LEAD AND GENERATOR SINCE THE HIGH IMPEDANCE WAS PRESENT. NO ADVERSE EVENTS HAVE BEEN REPORTED. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS. ATTEMPTS FOR THE RETURN OF THE EXPLANTED LEAD AND GENERATOR HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 4105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |