FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1203184
·
Received October 17, 2008
Report
- Report Number
- 1644487-2008-02527
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- August 21, 2008
- Report Date
- September 26, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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
REPORTER INDICATED THAT A PATIENT HAD LACK OF EFFICACY DUE TO HIGH LEAD IMPEDANCE READINGS FIRST NOTED IN 2006. THE REPORTER WAS ADVISED TO DISABLE THE VNS DUE TO THE HIGH LEAD IMPEDANCE. THE PATIENT WAS REFERRED FOR A SURGICAL CONSULT FOR POSSIBLE VNS REVISION SURGERY, BUT DID NOT SHOW FOR THE APPOINTMENT. TO DATE, THE PATIENT HAS NOT RESCHEDULED. ANY EXPLANTED VNS DEVICES HAVE BEEN REQUESTED FOR RETURN IF SURGERY OCCURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 36236C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |