FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1081928
·
Received July 23, 2008
Report
- Report Number
- 1644487-2008-01664
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- January 1, 2008
- Report Date
- June 23, 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
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
PATIENT UNDERWENT GENERATOR END OF SERVICE GENERATOR REPLACEMENT SURGERY. UPON CONNECTING THE NEW GENERATOR TO THE EXISTING LEAD, SYSTEMS DIAGNOSTICS RESULTED IN HIGH IMPEDANCE. TROUBLESHOOTING EFFORTS TO ENSURE PROPER CONNECTION BETWEEN THE GENERATOR AND LEAD DID NOT RESOLVE THE HIGH IMPEDANCE EVENT AND THE LEAD WAS SUBSEQUENTLY REPLACED. PRODUCT ANALYSIS WILL BE PERFORMED ONCE PRODUCT IS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 19227C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |