FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR LEAD MODEL
MDR report key: 1041283
·
Received May 9, 2008
Report
- Report Number
- 1644487-2008-01123
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 24, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
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
INITIAL REPORTER INDICATED THAT IN EARLY 2008, THEY HAD THEIR VNS REMOVED BECAUSE OF A BROKEN LEAD WIRE. X-RAYS WERE TAKEN PER THE PATIENT AND SHOWED THAT LEAD WIRE WAS BROKEN. PHYSICIAN ALSO FOUND NO ACTIVITY WHEN DOING DIAGNOSTICS. NO TRAUMA OR MANIPULATION WAS REPORTED. THE EVENT WAS REPORTED BY THE PATIENT AND NO FURTHER CONTACT INFORMATION HAS BEEN PROVIDED TO FOLLOW UP WITH THE PATIENT'S PHYSICIAN. A DEVICE MALFUNCTION IS SUSPECTED AGAINST THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOLAR LEAD MODEL | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |