FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR LEAD MODEL 300
MDR report key: 1022118
·
Received March 25, 2008
Report
- Report Number
- 1644487-2008-00782
- Event Type
- Malfunction
- Date Received
- March 25, 2008
- Date of Event
- January 1, 2008
- Report Date
- February 26, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
X-RAYS REVIEWED BY MFR. YIELDED NO LEAD DISCONTINUITIES. 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 THE PT HAD HIGH LEAD IMPEDANCE INDICATING A POSSIBLE LEAD MALFUNCTION. IT WAS ADDITIONALLY REPORTED THE PT WAS NOT FEELING STIMULATION. THE PT DID NOT HAVE ANY FALLS OR INJURIES PRECEDING THE HIGH IMPEDANCE EVENT. X-RAYS REVIEWED BY MFR YIELDED NO GROSS LEAD DISCONTINUITIES. REVISION SURGERY IS LIKELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOLAR LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 11070C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |