FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 302
MDR report key: 1000799
·
Received February 21, 2008
Report
- Report Number
- 1644487-2008-00362
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- January 1, 2008
- Report Date
- January 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED.
Description of Event or Problem · 1
REPORTER INDICATED A VNS PT HAD HIGH LEAD IMPEDANCE READINGS AT AN OFFICE VISIT. THE VNS WAS DISABLED. THE PT FALLS FREQUENTLY BUT DOES NOT MANIPULATE THE VNS. X-RAYS REVIEWED BY THE REPORTER DID NOT REVEAL ANY LEAD ANOMALIES. THE PT HAS HAD AN INCREASE IN SEIZURES THAT ARE GREATER THAN PRE-VNS BASELINE LEVEL. THE REPORTER STATED THE SEIZURE INCREASES IS RELATED TO THE HIGH LEAD IMPEDANCE. LEAD REVISION SURGERY IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-30 | 6900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |