FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL UNK
MDR report key: 2061814
·
Received March 30, 2011
Report
- Report Number
- 1644487-2011-00674
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- February 3, 2011
- Report Date
- August 18, 2017
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT HIGH LEAD IMPEDANCE WAS NOTED WITH SYSTEMS AND NORMAL MODE DIAGNOSTICS TESTING AT AN OFFICE VISIT. VNS PROGRAMMING HISTORY RECEIVED FROM THE REPORTER DID NOT IDENTIFY HIGH LEAD IMPEDANCE IN THE PROGRAMMING HISTORY. VNS REVISION SURGERY IS PLANNED, BUT A SURGERY DATE HAS NOT BEEN SET. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL UNK | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female |