FDA Adverse Event
Injury
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1063453
·
Received June 20, 2008
Report
- Report Number
- 1644487-2008-01440
- Event Type
- Injury
- Date Received
- June 20, 2008
- Date of Event
- April 3, 2008
- Report Date
- May 23, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, AN ACUTE ANGLE WAS VISUALIZED. 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 VNS PT EXPERIENCED PAINFUL STIMULATION AT THE BACK OF THE LEFT EAR RADIATING TO THE FRONT OF HIS HEAD. DIAGNOSTIC TEST RESULTS WERE WITHIN NORMAL LIMITS. THE PAIN RESOLVED ONCE STIMULATION WAS PROGRAMMED OFF. X-RAYS WERE REVIEWED AND STRAIN RELIEF WAS NOT PLACED PER LABELING RECOMMENDATIONS. ADDITIONALLY, AN ACUTE ANGLE WAS VISUALIZED NEAR THE BIFURCATION. THE PT IS BEING SENT FOR REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |