FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1781124
·
Received July 29, 2010
Report
- Report Number
- 1644487-2010-01761
- Event Type
- Malfunction
- Date Received
- July 29, 2010
- Date of Event
- May 11, 2010
- Report Date
- June 29, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
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
A REVIEW OF THE PATIENT'S VNS PROGRAMMING HISTORY INDICATES THAT HIGH IMPEDANCE WAS FIRST OBSERVED ON (B)(6) 2010. ADDITIONALLY, PER THE PROGRAMMING HISTORY, IT APPEARS THE VNS DEVICE WAS NOT DISABLED ON (B)(6) 2010.
Description of Event or Problem · 1
REPORTER INDICATED HIGH LEAD IMPEDANCE READINGS WERE OBTAINED FOR A VNS PT AT AN OFFICE VISIT. X-RAYS NOTED A LEAD BREAK PER THE REPORTER. THE PT HAD RECENT FALL TRAUMA DUE TO A SEIZURE. ATTEMPTS FOR ADDITIONAL INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 4919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Male |