FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR LEAD MODEL 300
MDR report key: 1881261
·
Received October 6, 2010
Report
- Report Number
- 1644487-2010-02247
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Date of Event
- August 1, 2010
- Report Date
- September 7, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, 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
IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT WHEN HE PERFORMED NORMAL MODE DIAGNOSTICS ON THE PT, HE GOT HIGH LEAD IMPEDANCE WARNING. NO TRAUMA OR MANIPULATION TO THE DEVICE WAS REPORTED. PHYSICIAN DID NOT KNOW WHEN THE LAST GOOD DIAGNOSTICS RESULTS WERE OBTAINED AS THIS WAS THE FIRST TIME HE TREATED THE PT. PHYSICIAN WAS ADVISED TO TURN OFF THE DEVICE AND TAKE X-RAYS. PT WILL LIKELY UNDERGO A FULL REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOLAR LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 4309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |