FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR LEAD MODEL 302
MDR report key: 1220045
·
Received October 31, 2008
Report
- Report Number
- 1644487-2008-02639
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 3, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
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
IT WAS REPORTED THAT THE DOCTOR GOT A HIGH LEAD IMPEDANCE DURING RE-IMPLANTATION OF THE NEW GENERATOR. THE SURGEON ALSO SAW FLUID IN THE OUTER TUBING OF THE LEAD WIRE. HE INDICATED THAT HE DID NOT SEE ANY PUNCTURE IN THE INNER TUBING. THE SURGEON REPORTED THAT THE LEAD WIRE COULD HAVE BEEN COMPROMISED WHILE EXPLANTING THE OLD GENERATOR. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT HAVE BEEN UNSUCCESSFUL TILL DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOLAR LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 9771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |