FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 829734
·
Received October 20, 2006
Report
- Report Number
- 1644487-2006-00399
- Event Type
- Malfunction
- Date Received
- October 20, 2006
- Report Date
- September 22, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- p970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
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
MANUFACTURER NOTIFIED OF SCHEDULED REVISON SURGERY DUE TO SYSTEM DIAGNOSIS AT OFFICE VISIT RESULTING IN HIGH LEAD IMPEDANCE, INDICATING POSSIBLE LEAD MALFUNCTION. CT SCAN RESULTS REPORTED FROM SITE DID NOT YIELD ANY LEAD DISCONTINUITIES. PREOPERATIVE SYSTEM DIAGNOSTICS RESULTED IN HIGH LEAD IMPEDANCE, CONFIRMING THE SUSPECTED LEAD MALFUNCTION. CYBERONICS, INC. REPRESENTATIVE IN ATTENDANCE DURING THE SURGERY REPORTED THE PHYSICIAN DID NOT VISUALIZE ANY LEAD DISCONTINUITIES DURING THE REPLACEMENT PROCEDURE. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | MUZ | CYBERONICS, INC. | 300-20 | 258222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |