FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1123807
·
Received August 15, 2008
Report
- Report Number
- 1644487-2008-01918
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- June 30, 2008
- Report Date
- July 17, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: 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 VNS PATIENT UNDERWENT VNS LEAD AND GENERATOR REVISION SURGERY DUE TO HIGH LEAD IMPEDANCE THAT WAS NOTED PRIOR TO THE SURGERY. IT IS NOT KNOWN IF THE PATIENT EXPERIENCED AND TRAUMA OR MANIPULATED THE VNS. THE EXPLANTED DEVICES HAVE BEEN REQUESTED FOR RETURN BUT HAVE NOT BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 5549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |