FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 302
MDR report key: 3140207
·
Received May 31, 2013
Report
- Report Number
- 1644487-2013-01647
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Date of Event
- April 30, 2008
- Report Date
- May 7, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
AS PART OF A RETROSPECTIVE REVIEW OF PROGRAMMING HISTORY DATA IN THE PROGRAMMING HISTORY DATABASE IT WAS IDENTIFIED THAT A VNS PATIENT HAD HIGH LEAD IMPEDANCE. GOOD FAITH ATTEMPTS WILL BE MADE FOR FURTHER DETAILS ABOUT THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 242465 | BIPOL LEAD MODEL 302 | BIPOL LEAD MODEL 302 | LYJ | CYBERONICS INC | 300-20 | 22429C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |