FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1041184
·
Received May 9, 2008
Report
- Report Number
- 1644487-2008-01118
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 11, 2008
- Report Date
- April 11, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THE PT PRESENTED AT OFFICE VISIT WITH HIGH IMPEDANCE ON SYS DIAGNOSTICS. X-RAYS REVIEWED BY THE PHYSICIAN REVEALED THE "LEAD PIN MIGRATED FROM THE GENERATOR ABOUT 2CM." NO TRAUMA OR MANIPULATION WAS REPORTED. THE PT UNDERWENT VNS THERAPY SYS REPLACEMENT SURGERY. THE GENERATOR WAS REPLACED PROPHYLACTICALLY, AND THE LEAD WAS REPLACED DUE TO THE REPORTED HIGH IMPEDANCE. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 1115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |