FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1052247
·
Received May 23, 2008
Report
- Report Number
- 1644487-2008-01206
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
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
REPORTER INDICATED THAT DIAGNOSTIC TESTING PERFORMED ON THE PT'S DEVICE YIELDED HIGH LEAD IMPEDANCE, INDICATING A PROBABLE LEAD MALFUNCTION. PT BEING SCHEDULED FOR REVISION SURGERY. GOOD FAITH ATTEMPTS FOR FURTHER INFO ARE CURRENTLY BEING MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 6593 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |